ROCHE DIAGNOSTICS GMBH

FDA Device Registration & Listing · MANNHEIM Baden-Wurttemberg, DE · Registration 9610126

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610126
FEI Number
3002806559
Entity Name
ROCHE DIAGNOSTICS GMBH
City/State/Country
MANNHEIM Baden-Wurttemberg, DE
Establishment Address
SANDHOFER STRASSE 116, MANNHEIM Baden-Wurttemberg D-68305, DE
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Roche Diagnostics Operations Inc. (Owner Number: 9039767)
Owner / Operator Contact Address
9115 Hague Road, Indianapolis, IN 46250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P090008

All Registered Proprietary Names

CAPILLARY TUBES 115 uL CAPILLARY TUBES 200 uL Total Protein Gen.2 TP2, 1050T, cobas c 503 Elecsys Vitamin D total III Vitamin D total G3 Elecsys cobas e 100 Vitamin D total G3 Elecsys E2G 300 PRECISET SERUM PROTEINS CALIBRATOR PRECISET PLASMAPROTEIN PRECISET Serumprotein CA, Gen.2, 400Tests, cobas c111 Calcium Gen.2, 2250Tests, cobas c 701 cobas c 70X CALCIUM GEN 2/2250 CA, Gen.2, 300Tests, cobas c,Integra cobas INTEGRA CALCIUM GEN 2 300 Calcium Gen.2 CA2, 1500T, cobas c 503 CALCIUM GEN. 2 cobas c 513 Analyzer cobas c 513 software Tina-quant Hemoglobin A1cDx Gen. 3 HBA1cDx TQ, Gen.3, 500 Tests cobas c513 cobas c513 cobas c513 analyzer commercial system Unsaturated Iron-Binding Capacity UIBC, 100T, cobas c 503 LumiraDx SARS-CoV-2 Ag (48T)EUA ,EN-US LumiraDx Instrument V5E (EN,US) EUA LumiraDx SARS-CoV-2 Ag Quality Controls LumiraDx SARS-CoV-2 Ag Control (2pk)EUA LumiraDx SARS-CoV-2 Ag Test LMDx Instrument V5E (EN,US) EUA,Serviced cobas THC HITACHI CANNABINOIDS II (911-12,917,P) ONLINE DAT Cannabinoids II THC2, 850T, cobas c 503 THC2, 150T, cobas c 503 cobas e-ELECSYS hGH CC 5 hGH CS Elecsys ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 TINA-QUANT PREALBUMIN PREA, 100Tests, cobas c, Integra PREA 150Tests cobas c 701 Prealbumin PREA, 200T, cobas c 503 TINA-QUANT PREALBUMIN ASSAY proBNP G2 STAT Elecsys cobas e 100 Elecsys ProBNP II Stat cobas e-ELECSYS PROBNP II STAT proBNP STAT CS Elecsys ELECSYS PROBNP II STAT IMMUNOASSAY ELECSYS PROBNP II CALSET PreciControl Rubella IgG Elecsys Rubella IgG PreciControl ELECSYS RUBELLA IGG IMMUNOASSAY Elecsys PreciControl Rubella IgG Rubella IgG Elecsys E2G 300 Rubella IgG PC Elecsys Rubella IgG Elecsys cobas e 100 Rubella IgG Elecsys cobas e PreciControl Rubella IgG Elecsys,cobas e N-Acetylprocainamide cobas NAPA/100 NAPA2, 100T, cobas c 503 ONLINE TDM N-acetylprocainamide TDM N-ACETYLPROCAINAMIDE HCG STAT Elecsys cobas e 100 V2 HCG Test Roche Diagnostics ELECSYS HCG Test System ELECSYS HCG TEST SYSTEM Elecsys HCG ELECSYS TOXO IgG Immunoassay Toxo IgG PC Elecsys Toxo IgG Elecsys E2G 300 PreciControl Toxo IgG Elecsys,cobas e TOXO IgG Toxo IgG Elecsys cobas e 100 Toxo IgG Elecsys cobas e ALKALINE PHOSPHATASE Pancreas a - Amylase 100 c111 cobas c 70X Amylase-pancreatic/600 AMY-P, 200Tests, cobas c, Integra Pankreas a - Amylase 100 c111 AMYL-P 600Tests cobas c701 CRP T CONTROL N PRODUCTS CRP N Control 5x0,5ML Elecsys HCG Test System HCG STAT Elecsys E2G 100 V2 HCG STAT Elecsys cobas e 100 V3 CRP Gen.4 250Tests cobas c501/INT CRP Gen.4, 200Tests cobas c111 CRP Gen.4 500Tests cobas c701/702 Tina-quant C-Reactive Protein IV CRP4, 500T, cobas c 503 HSV-2 IgG Elecsys E2G 100 Elecsys HSV-2 IgG HSV-2 IgG Elecsys cobas e 100 ELECSYS HSV-2 IGG IMMUNOASSAY ELECSYS CA 15-3 TEST SYSTEM Elecsys CA 15-3 CA 15-3 G2 CS Elecsys ELECSYS TESTOSTERONE CALSET II Testosterone G2 CS G2 Elecsys V2.1 Testosterone CS Gen.2.1 Elecsys,cobas e Testosterone II CalSet II LDLC3 LDL-Cholesterol Gen. 3 LDL-C Gen.3, 500Tests, cobas c701,702 LDL-C Gen.3, 100Tests, cobas c111 LDL-C Gen.3, 200Tests, cobas c,Int LDL-Cholesterol Gen.3 LDLC3, 600T, cobas c 503 SW cobas NG ASAP 11.1 SW COBAS 6800/8800 0138.1011 SW cobas CT ASAP 11.1 KIT COBAS 6800/8800 CT/NG RMC IVD cobas® CT/NG for use on cobas® 6800/8800 systems KIT COBAS 6800/8800 CT/NG 480T IVD SW cobas CT/NG ASAP 11.1 cobas® CT/NG Positive Control Kit cobas® CT/NG Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 Systems KIT COBAS 58/68/8800 CT/NG RMC IVD KIT COBAS 58/68/8800 CT/NG 480T IVD cobas® PCR Urine Sample Kit cobas® PCR Media Uni Swab Sample Kit cobas® PCR Media Dual Swab Sample Kit HbA1c TQ haemolyzing rg,cobas Integra800 HbA1c TQ haemolyzing rgt, cobas c DIGOXIN, 250Tests, cobas c, Integra Haemolyse reagent 800T cobas c 111 Cobas Integra Albumin (ALB-T) (Turbidimetric) Cobas Integra HbA1c Cobas Integra Digoxin (DIG) modification ONLINE TDM Digoxin DIG, 500Tests, cobas c503 CA 15-3 G2 Elecsys E2G 300 Elecsys CA 15-3 II CA 15-3 G2 CS Elecsys cobas c 70X AST/740 ISE CHLORID ELEKTR. cobas c 111 system ISE REFERENCE SOL. cobas c 111 system Aspartate Aminotransferase (AST)(S GOT) cobas C (111) CHLORIDE ELECTRODE ISE ISE Chloride Electrode ISE CALIBRATION KIT cobas c 111 system cobas C (111) SODIUM ELECTRODE ISE ISE Potassium Electrode cobas C (111) GLUCOSE Glucose 400T cobas c 111 ISE Sodium Electrode cobas C (111) AST AST/GOT 400T cobas c 111 C-Reactive Protein ISE SODIUM ELECTR. cobas c 111 system ISE CALIB. IND./URINE cobas c 111 system CRP HS 100T cobas c111 ASTPM, 740Tests, cobas c 701 cobas C (111) POTASSIUM ELECTRODE ISE ISE POTASSIUM ELECTR. cobas c 111 system Glucose HK COBAS C 111 ANALYZER Ionify iST2 cobas i 450T Ionify 17-Hydroxyprogesterone cobas Cdiff Nucleic acid test for use on the cobas Liat System KIT COBAS LIAT CDIFF IVD cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System KIT COBAS LIAT CDIFF Controls Vitamin D CS Elecsys Elecsys Vitamin D Vitamin D CC 5 Elecsys Vitamin D Elecsys cobas e 100 Elecsys Vitamin D Calcheck 5 Elecsys Vitamin D assay, Elecsys Vitamin D CalSet, Elecsys PreciControl Varia 3 Free PSA CalCheck FREE PSA CALSET cobas e-ELECSYS FREE PSA GEN.2 free PSA Elecsys cobas e 100 V2 Free PSA CC 3 Elecsys free PSA CS Elecsys V2 Elecsys free PSA free PSA CalSet free PSA Elecsys E2G 300 free PSA Gen.2 Elecsys,cobas e free PSA Elecsys cobas e 100 V3 free PSA CalCheck free PSA CS Elecsys V3 free PSA Elecsys E2G 300 V2 Elecsys free PSA Test System free PSA Elecsys E2G 100 V2 ELECSYS TSH CALSET W/MODELS TSH CS Elecsys V2 Elecsys TSH CalSet cobas x480 system cobas z480 system cobas HPV Test cobas z480 Analyzer cobas 4800 System Wash Buffer Kit, 960 Tests cobas Sample Prep Buffer cobas 4800 System cobas HPV AP software cobas 4800 System Sample Preparation Kit, 240 Tests SW OSWIN7 RECSYS RP5800-C4800 V2.1.1 DVD cobas 4800 HPV Amplification/Detection Kit, 960 Tests KIT cobas 4800 HPV CONTROLS 10 SETS IVD KIT cobas 4800 HPV AMP/DET 240T US-IVD KIT cobas 4800 SYS WASH BUFFER 960T IVD cobas 4800 HPV Controls Kit, 10 Sets KIT cobas 4800 SYS SAMPLE PREP 240T IVD KIT cobas 4800 SYS WASH BUFFER 240T IVD cobas 4800 System Wash Buffer Kit, 240 Tests KIT cobas 4800 SYS SAMPLE PREP 960T IVD KIT cobas 4800 SYS LIQ CYT PREP 960T IVD cobas 4800 System Liquid Cytology Preparation Kit, 960 Tests SW C4800 HPV AP v2.1 CD KIT COBAS SAMPLE PREP BUFFER 480T IVD KIT cobas 4800 SYS LIQ CYT PREP 240T IVD KIT cobas 4800 HPV AMP/DET 960T US-IVD cobas 4800 System Liquid Cytology Preparation Kit, 240 Tests cobas 4800 HPV Amplification/Detection Kit, 240 Tests cobas 4800 System Sample Preparation Kit, 960 Tests SW COBAS 4800 FSE TOOLS CD 3 SW cobas 4800 UDF v2 CD CREP Gen.2, 250Tests, cobas c, Integra cobas INTEGRA CREATININE + WALDENSTROM Crea PAP 200T cobas c111 CREP Gen.2, 600Tests, cobas c701 Creatinine Plus Ver. 2 CREP2, 600T, cobas c 503 COBAS INTEGRA CREATININE PLUS VER.2 ASSAY cobas u 601 urine analyzer cobas u pack [400 strips] cobas u 601 urinalysis test system AMMONIA/ETHANOL/CO2 CALIBRATORs AMMON/ETH/CO2 ABNORM CTRL NH3/ETH/CO2 Control A NH3/ETH/CO2 Calibrator NH3/ETH/CO2 Control N AMMON/ETH/CO2 NORMAL CTRL AMMONIA/ETHANOL/CO2 CAL AMMONIA/ETHANOL/CO2 Controls CMV IgM Elecsys E2G 300 Lithium cobas c LITHIUM, 100Tests, cobas c Lithium LITHIUM, 500Tests, cobas c503 ELECTRODE ISE LITHIUM HAPT Gen.2, 150Tests, cobas c 701 cobas INTEGRA D-DIMER D-Dimer, 100 Tests, cobas c, Integra TINA-QUANT a D-Dimer D-Dimer, 100Tests, cobas c503 Tina-quant D-Dimer KIT COBAS 4800 HSV 1/2 CONTROLS IVD KIT COBAS 4800 HSV 1&2 AMP/DET 80T IVD cobas e 801 immunoassay Analyzer cobas e 801 module OS Win10 Recovery USB c8000 DM Update USB-Stick USB 3 32GB Cobas 8000 OS Win10 Recovery USB c8000 DM Migration Cortisol G2 Elecsys cobas e 100 Cortisol II CalSet Cortisol G2 CS Elecsys Elecsys Cortisol II Cortisol G2 Elecsys E2G 300 COBAS INTEGRA CHOLESTEROL GEN. 2 Cholesterin 400T cobas c 111 cobas c 70X Cholesterol/2100 CHOL HiCo Gen.2, 2100Tests, cobas c701 CHOL HiCo Gen.2, 400Tests, cobas c, Int. Cholesterol Gen.2 Cholesterol Bio cobas C (111) CHOL 2 CHOL2, 2600T, cobas c 503 cobas HBV/HCV/HIV-1 Control Kit (HPC and LPC) in cassettes Specimen preparation reagents (cobas omni Reagents) cobas 6800/8800 Systems cobas NHP Negative Control Kit in cassettes ELECSYS PROLACTIN Prolactin G2 Elecsys E2G 300 ELECSYS PROLACTIN ASSAY Prolactin G2 Elecsys cobas e 100 V2.1 Elecsys Prolactin II A1CX3, 200T, cobas c 503 Tina-quant Hemoglobin A1cDx Gen.3 A1CX3, 500T, cobas c 503 H HBA1C HEMOLYZING REAGENT GLUC HK Gen.3, 800Tests, cobas c, Int. cobas INTEGRA GLUCOSE HK GEN 3 GLUC HK Gen.3, 2200Tests, cobas c701 Glucose HK Gen. 3 COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM ELECSYS T4 ASSAY T4 Elecsys E2G 300 T4 Elecsys cobas e 200 V2 T4 CS Elecsys V2 cobas 6800 instrument cobas 8800 instrument KIT COBAS 6800/8800 BUFF NEG RMC IVD KIT COBAS 6800/8800 UTIL CHAN 96T IVD Digital LightCycler® Analyzer Digital LC Analyzer cobas 5800 instrument LightCycler PRO, 96 Digital LC Partitioning Engine LightCycler PRO, 384 KIT COBAS 58/68/8800 BUFF NEG RMC B-CrossLaps CC5 Elecsys Oxycodone 200Test cobas c OXY 200Tests, cobas c PRECICONTROL CLINCHEM MULTI 1, 4X5 ML PreciControl Clinchem Multi 2 PreciControl Clinchem Multi 2, 4X5 ml PreciControl Clinchem Multi 1 PRECICONTROL CLINCHEM MULTI 1 AND 2 Elecsys 2010 cobas E 2010 cobas e411 Analyzer cobas Elecsys 2010 Analyzer EVO ADDITIONAL E MODULE cobas e 411 SW version 02-08 Install CD HITACHI TOBRAMYCIN (911,912,917,P) cobas TOBRAMYCIN/100 TOBR2, 100T, cobas c 503 ONLINE TDM Tobramycin ONLINE TDM TOBRAMYCIN ELECSYS MYOGLOBIN ASSAY Myoglobin STAT CS Elecsys Myoglobin Elecsys cobas e 100 Myoglobin Elecsys cobas e cobas BENZ/200 cobas BENZODIAZEPINES ONLINE DAT Benzodiazepines Plus BENZ, 850T, cobas c 503 cobas INTEGRA CYCLOSPORINE SAMP PRETREAT cobas c Integra CSA II 100 Tests cobas Integra Calibrator Cyclosporin cobas Integra Negativ-Calibr Cyclosporin EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY Elecsys CK-MB STAT Immunoassay CK-MB STAT Elecsys cobas e 100 V4 Elecsys Anti-HBc IgM Anti-HBc IgM PC Elecsys Elecsys Anti-HBCIG PreciControl Anti-HBc IgM Anti-HBc IgM Elecsys cobas e 100 ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV HSV PC Elecsys HSV-1 IgG Elecsys E2G 100 HSV-1 IgG Elecsys cobas e 100 Elecsys HSV-1 IgG COBAS INTEGRA REAGENT CASSETTES IGG, 100Tests, cobas Integra cobas INTEGRA IGA 100 IGA, 100Tests, cobas Integra IGM, 100Tests, cobas Integra cobas e-ELECSYS FERRITIN [200] Ferritin Elecsys cobas e 100 V2 ELECSYS FERRITIN PRODUCTS Ferritin Elecsys E2G 300 cobas e-ELECSYS FERRITIN [100] Ferritin CS Elecsys V2 Ferritin Elecsys cobas e 200 Ferritin Gen.2 Elecsys,cobas e ELECSYS IGE II IMMUNOASSAY IgE G2 Elecsys E2G 100 IgE G2 Elecsys cobas e 100 Elecsys IgE II IgE Gen.2 Elecsys,cobas e KIT DNA ISOLATION 24T IVD cobas BRAF V600 Mutation Test cobas c 70X MAGNESIUM/200 MG Gen.2, 250Tests, cobas c MG2, 690T, cobas c 503 Magnesium Gen.2, 100 Tests, cobas c111 Magnesium Gen.2 FERR Gen.4, 650Tests cobas c 701 FERR Gen.4, 250Tests cobas c Ferritin Gen 4. Tina-quant Ferritin Gen.4 FERR4, 400T, cobas c 503 cobas e-ELECSYS ANTI-TPO CS Anti-TPO CS Elecsys ELECSYS ANTI-TPO CALSET LDH 100T cobas c 111 LACT Gen.2, 225Tests, cobas c 701 Lactate 100Tests cobas c111 LDHI Gen.2 acc.IFCC, 300T, cobas c, Int. LDHI Gen. 2 acc.IFCC, 750T, cobas C701 Lactate Dehydrogenase acc. to IFCC ver.2 Lactate Gen.2 LACT2, 100T, cobas c 503 LDHI2, 850T, cobas c 503 AMH Elecsys cobas e 100 V2 AMH Elecsys E2G 100 V2 CK 200Tests, cobas c111 CK 200Tests Creatine Kinase CK 200 Tests, cobas c/Integra CK, 500Tests, cobas c503 ELECSYS LH ASSAY Elecsys LH LH Elecsys cobas e 100 LH Elecsys cobas e Myoglobin CS Elecsys E2G Elecsys Myoglobin Myoglobin CS Elecsys Myoglobin Elecsys E2G 100 Myoglobin STAT Elecsys cobas e 100 Myoglobin STAT Elecsys cobas e Elecsys Myoglobin Immunoassay Myoglobin Elecsys,cobas e Myoglobin STAT Elecsys,cobas e cobas c Integra ACETA 150 Test Acetaminophen ROCHE ACETAMINOPHEN ASSAY Elecsys Syphilis Syphilis Elecsys E2G 20x300 Syphilis PC Elecsys Syphilis PC Release Elecsys PreciControl HIV Gen II PreciControl Growth Elecsys cobas e PreciControl Growth PreciControl Universal Elecsys Elecsys PreciControl Universal PreciControl Universal PreciControl TM Elecsys PreciControl Tumor Marker Elecsys Calcitonin CalCheck 5 PreciControl MultiMarker PreciControl Thyro AB Elecsys V2 PreciControl Varia PreciControl Cardiac II Troponin PC Elecsys TDM Control Set HIV PC G2 Elecsys Ionify ControlSet Steroids and Vitamin D Ionify ConSet iSV cobas i (2x10x5ml) PreciControl Phospho-Tau (181P) Plasma pTau PC Elecsys pT181p PC Elecsys HIV PC G2 Elecsys lq Estradiol G3 Elecsys cobas e 100 Elecsys Estradiol Assay Elecsys Estradiol Estradiol G3 Elecsys E2G 300 Elecsys Estradiol III Ionify Estradiol HCG+beta Elecsys E2G 300 ELECSYS HCG+BETA CALSET II ELECSYS HCG AND BETA TEST SYSTEM Elecsys HCG and Beta HCG+beta II Elecsys,cobas e HCG+beta Elecsys cobas e 100 V2 HCG+beta CS Elecsys V2 HCG+beta Elecsys E2G 100 V1 Phosphate (inorganic) ver.2 PHOS2, 750T, cobas c 503 PTH G2 CS Elecsys PTH G2 STAT CS Elecsys A2M Calibrator Kit PTH G2 CS Elecsys E2G Calibrator b2-MICROGLOBULIN Elecsys FT3 III CalSet Elecsys HCG STAT CalSet II FT3 G3 CS Elecsys V2 HCG STAT Elecsys CS V3 FT4 G4 CS Elecsys Anti-TG Elecsys CS V2 CalSet FT4 IV PreciControl Cortisol Urine PreciControl Syphilis IGF-1 CC5 Elecsys CalCheck IGFBP-3 Control-Set b2-MICROGLOBULIN A2M Serum Control Kit PreciControl TS Elecsys TSH CC 5 Elecsys Elecsys total PSA CalCheck PreciControl Maternal Care Gen.2 Total PSA CC 3 Elecsys IGFBP-3 CC5 Elecsys PCT CC 5 Elecsys Elecsys CA 125 II CalCheck Elecsys CA 19-9 CalCheck 5 PreciControl TS Elecsys Insulin CalCheck 5 Elecsys CalCheck Testosterone PreciControl CMV IgG Elecsys HE4 CalCheck 5 Elecsys HCG STAT CalCheck 5 Elecsys CalCheck T-Uptake Elecsys Estradiol III CalCheck AFP CalCheck Elecsys Myoglobin CalCheck 5 Elecsys ?-CrossLaps CalCheck Elecsys Vitamin B12 CalCheck PreciControl Toxo IgG PreciControl Anti-HAV IgM Elecsys Toxo IgG CalCheck 5 TSH CalCheck 5 Elecsys CEA CalCheck 5 Elecsys T4 CalCheck 5 Elecsys C-Peptide CalCheck 5 Elecsys TSH CalCheck 5 Elecsys Anti-CCP CalCheck CalCheck Androstenedione PreciControl HE4 Elecsys Digoxin CalCheck 5 Elecsys N-MID Osteocalcin CalCheck 5 PreciControl Maternal Care Androstenedione CC5 Elecsys Elecsys PCT CalCheck 5 Elecsys Troponin T CalCheck 5 Elecsys hGH CalCheck 5 Elecsys ACTH CalCheck Precicontrol Troponin T Elecsys Prolactin II CalCheck 5 Elecsys Troponin I CalCheck 5 Elecsys Anti-TPO CalCheck Elecsys Progesterone III CalCheck 5 Elecsys SHBG CalCheck 5 Elecsys Rubella IgG CalCheck 5 PreciControl Anti-CCP Elecsys Folate RBC CalCheck Elecsys CK-MB CalCheck 5 Elecsys IgE CalCheck 5 Elecsys proBNP II CalCheck 5 Elecsys Vitamin D CalCheck 5 Anti-TSHR CC 3 Elecsys Elecsys PTH CalCheck 5 Elecsys Ferritin CalCheck 5 Elecsys CA 15-3 II CalCheck 5 Elecsys Folate III CalCheck Vitamin D total G2 PC Elecsys V2 PreciControl Rubella IgM PreciControl HSV PreciControl CMV IgM Elecsys DHEA-S CalCheck 5 Elecsys CalCheck FT 3 PreciControl Anti-HAV Elecsys Anti-Tg CalCheck Elecsys LH CalCheck 5 Elecsys T3 CalCheck 5 Elecsys FT4 CalCheck PreciControl Rubella IgG PreciControl Vitamin D total III Vitamin D total G3 CC 5 Elecsys AMH PC Elecsys CalCheck Vitamin D total III Troponin T Gen 5 CC 5 Elecsys Syphilis PC Elecsys CalChecks ?-Amyloid (1-42) II AMH CC 5 Elecsys beta-Amyloid(1-42) CC 5 Elecsys pTau CC 5 Elecsys PTH STAT CS Elecsys V3 tTau PC Elecsys Precicontrol Total-Tau TG G2 CC 5 Elecsys tTau CC5 Elecsys PTH CS G2 Elecsys E2G V2 CalChecks Phospho-Tau (181P) PreciControl LPA Gen.2 beta-Amyloid(1-42) G2 PC Elecsys Cortisol Urine PC Elecsys PreciControl ?-Amyloid (1-42) II ELECSYS ANTI-CCP CALCHECK KIT PTH Elecsys CS V3 Syphilis PC Elecsys lq Toxo IgM PC Elecsys Cfas CK.MB 3x1ML Calibrator for Automated Systems CK-MB cobas INTEGRA CFAS CKMB ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS (CK-MB) FSH Elecsys,cobas e Elecsys FSH FSH Elecsys E2G 300 V2 FSH Elecsys cobas e 100 V2 Elecsys TSH TSH Elecsys E2G 300 V2 TSH Elecsys cobas e 200 V2 Cfas Proteins Cfas PAC 3x1ML COBAS U411 TEST SYSTEM cobas u411 Chemstrip 10 UA cobas u 411 Urine Analyzer Troponin T Elecsys, cobas e Troponin T CS Elecsys V4 Troponin T Elecsys cobas e 200 ELECSYS TROPONIN T COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST cobas® liat CT, NG and MG control kit cobas® liat CT/NG nucleic acid test KIT COBAS LIAT CT/NG IVD cobas® liat CT/NG/MG nucleic acid test KIT COBAS LIAT CT/NG/MG IVD KIT COBAS LIAT CT/NG/MG CTL IVD SW USB COBAS LIAT CT/NG/MG V1.8 SW USB COBAS LIAT CT/NG V1.1 Aspartate Aminotransferase acc. to IFCC with pyridoxal phosphate activation ASTP, 500T, cobas c 503 Anti-SARS-CoV-2 Elecsys E2G 300 Anti-SARS-CoV-2 Elecsys cobas e 200 PreicControl Anti-SARS-CoV-2 Elecsys Anti-SARS-CoV-2 Anti-SARS-CoV-2 PC Elecsys CHOLINESTERASE TEST SYSTEM CHOLINESTERASE TEST SYSTEM PRODUCTS CHE Gen.2, 200Tests, cobas c, Integra Elecsys Digoxin CalSet Elecsys Digoxin CS ELECSYS DIGOXIN Digoxin Elecsys, cobas e Digoxin Elecsys cobas e 100 Digoxin CS Elecsys, cobas e Digoxin CS Elecsys ELECSYS HBSAG CONFIRMATORY Elecsys Tacrolimus Tacrolimus Elecsys E2G 300 cobas e-ELECSYS Tacrolimus beta-Amyloid(1-42) G2 Elecsys E2G 100 tTau Elecsys cobas e60 V2 beta-Amyloid(1-42) G2 Elecsys cobas e 60 tTau Elecsys E2G 100 V2 Elecsys Beta-Amyloid (1-42) CSF II Elecsys Total-Tau CSF CONTROL SET DAT CLINICAL CFAS DAT QUALITATIVE PLUS CLINICAL ROCHE C.F.A.S. DAT QUAL PLUS CALIBRATOR TG G2 Elecsys cobas e 100 V2 TG G2 Elecsys E2G 300 V2 Ionify CalSet Steroids and Vitamin D cobas u 601 urinalysis test system cobas U Calibration Strip, 25 Str. Ionify CalSet iSV cobas i (2x10x5ml) Cystatin C Control Set Gen.2 CFAS CYSTATIN C GEN2 cobas c CYSTATIN C GEN 2/225T Cfas Cystatin C Cystatin C Gen. 2 cobas c 70x CYSTATIN C GEN2/225 C.f.a.s Cystatin C CYSTATIN C GEN2 CONTROL SET cobas COCAINE/200 cobas COCAINE COC Gen.2, 850Tests, cobas c503 Cocaine ONLINE DAT II COCAINE II IRON STANDARD IRON Standard US Syphilis Elecsys E2G 300 V2 Syphilis Elecsys cobas e 100 V2 Elecsys Syphilis cobas 8000 C 502 MODULE Tina-quant IgA Gen.2 cobas 8000 cobas ISE MODULE [DOUBLE] cobas 8000 CORE UNIT cobas 8000 cobas C 701 MODULE ISE Indirect Na, K, Cl for Gen.2 cobas 8000 e 602 MODULE cobas 8000 c702 MODULE cobas c502 Analyzer cobas 8000 Data Manager cobas c702 Analyzer SCISE ISE Compensator cobas 8000 ISE Module cobas e602 Analyzer Self-Contained ISE Support Box cobas c701 Analyzer cobas 8000 Core COBAS 8000 C 502 MODULE CU SW DM c8000 V165 cobas 8000 system software SW Install CD c8000 V06-05 cobas 8000 CORE UNIT CU cobas 8000 Modular Analyzer Series SW WIN10 (2015) MIGRAT. KIT C8000 RP5810 SW c8000 data manager 168 cobas 8000 data manager CHEMSTRIP MICRAL URINE TEST STRIPS Elecsys Prolactin II Prolactin G2 Elecsys E2G 100 V1 Elecsys PTH STAT PTH Elecsys cobas e 100 V2 Elecsys PTH PTH Elecsys E2G 300 V2 PTH Elecsys E2G 100 V2 PTH STAT Elecsys cobas e 100 V2 Direct Bilirubin D BILI, 350T, cobas c503 BIL-T Gen.3, 400Tests cobas c 111 BIL-T Gen.3, 600Tests cobas c 701,702 BIL-T Gen.3, 250Tests cobas c,Integra BILT3, 1050T, cobas c 503 Bilirubin Total Gen.3 BIL-T Gen.3, 600T, cobas c 701,702 BIL-T Gen.3, 1050T, cobas c pack green BIL-T Gen.3, 250T, cobas c,Integra cobas p 680 Instrument cobas® 8800 System Total Protein 400T cobas c111 COBAS READY TOTAL PROTEIN REAGENT Aldolase Assay ALDOLASE ALDOLASE TC UV-TEST 100ML KIT COBAS 4800 EZH2 AMP/DET 24T IVD cobas® EZH2 Analysis Package Software version 1 cobas® EZH2 Mutation Test SW C4800 EZH2 AP V1 CD Elecsys Anti-CMV Elecsys Syphilis CoaguChek XS PT Test Strips CoaguChek XS 24 ct strip CoaguChek XS 6 tests International (en) COAGUCHEK XS SYSTEM COAGUCHEK XS Meter [CC-XS] CC-XS Meter cpl. COAGUCHEK XS PT TEST 6 STRIP CoaguChek XS 6 tests USA (en) COAGUCHEK XS PST CARE KIT ELECYS IGE ASSAY IgE CS Elecsys Elecsys IgE CoaguChek XS Plus System cobas BENZ II /200 BENZ2, 850T, cobas c pack green ONLINE DAT Benzodiazepines II Elecsys FSH FSH Elecsys E2G 100 V2 cobas b 221 SOL CTRL COOX/MSS VERIF 7x4 PreciControl Cardiac G2 Elecsys V4 Elecsys Digoxin Immunoassay Elecsys PreciControl Cardiac II Digoxin Elecsys cobas e 100 Digoxin Elecsys E2G 100 Elecsys Digoxin HSV PC Elecsys HSV-2 IgG Elecsys cobas e 100 V2 HSV-2 IgG Elecsys E2G 100 V2 cobas p 680 START-UP KIT MagNA Pure 24 Tip Park/Piercing Tool MagNA Pure 24 Piercing Tool MagNa Pure Compact Drip Tray MagNa Pure Lyser Rotor Lightcycler 2 Centrifuge MPLC CB, Reaction Tubes MP Compact Waste Tank MagNa Pure Compact Drop catcher Lightcycler O-Ring Cell Set cobas C311 AVENIO MILLISECT System SW cobas omni UCT 3.1 Lightcycler Color Compensation Set MagNa Pure RXN TIPS-LARGE Clot Catcher Pro [100 PCS] MagNa Pure LC Cool Block, Sample Carousel PC/CC-CUPS MagNa Pure Compact Tube Rack MPLC CB, 96-well PCR Plate MagNa Pure REAGENT TUB LID (Large) MagNa Lyser 115V MagNa Pure Waste accessories MagNa Pure Compact Cartridge Rack MagNa Pure LC 2 Instrument LIGHTCYCLER CLASSIC ROTOR UPGRADE KIT CLOT CATCHER [250 PC] MagNa Pure Compact Elution Tube Rack MPLC Reaction Tip (small) MPLC Greasing Set MPLC Reagent Tub (SMALL) MagNa Pure 96 Waste Rack IVD MPLC TUB LID (Small, Medium) Avenio Millisect System 2 MPLC Tub Lid (Large) MPLC O-Ring Maintenance Kit CONA, 100Tests, cobas c503 MagNa Pure 96 Reagent Rack IVD MPLC TUB LID SEAL Carry-over Needle Assessment MagNa Pure 96 Purification Rack IVD ISD Sample PT Elecsys cobas e 100 MagNa Pure Liquid Waste Funnel REFERENCE ELECTRODE ISE 91XX cobas Omni Processing Plate MICRO ELECTRODE REF MagNa Pure 96 Processing Plate cobas Omni Pipette Tips Instrument Check cobas Omni Amplification Plate MagNa Pure 96 Processing Cartridge MagNa Pure 96 Output Plate AssayTip/AssayCup tray ControlSet Vials Elecsys,cobas e LIGHTCYCLER ACCESSORIES CalSet Vials Elecsys,cobas e MagNA Pure 96 Dropcatcher IVD MAGNAPURE ACCESSORIES Tinaquant HBA1C Gen. 3 HbA1c TQ Gen.3, 200Tests,cobas c111 HbA1c TQ Gen.3, 150Tests,cobas c501/INT TQ HBA1C GEN3 HSV-1 IgG Elecsys cobas e 100 V2 HSV-1 IgG Elecsys E2G 100 V2 Elecsys HSV-1 IgG cobas 6800 System cobas 8800 System cobas HBV/HCV/HIV-1 Control Kit (HPC and LPC) in cassettes cobas HBV assay specific analysis package (ASAP) software Specimen preparation reagents (cobas omni Reagents) cobas NHP Negative Control Kit in cassettes cobas HBV in cassettes SW cobas HBV ASAP Software KIT COBAS 58/68/8800 HBV 192T IVD cobas® HBV Online Cocaine II COBAS INTEGRA COCAINE II 200 COBAS INTEGRA ONLINE DAT II COCAINE II Elecsys Progesterone III Progesterone G3 Elecsys cobas e 100 ELECSYS PROGESTERONE Elecsys Progesterone Assay Progesterone G3 Elecsys E2G 300 Progesterone G3 Elecsys E2G 100 V1 Amphetamines Gen. 2 cobas INTEGRA AMPH II 200 AMPHETAMINES II ASSAY ELECSYS C-PEPTIDE CALSET C-Peptide CS Elecsys Sample Supply Module V2 cobas 8800 v2 cobas 6800 v2 cobas 6800 2nd Analytical Unit cobas c 70X Ethanol/400 IRON2, 700T, cobas c 503 IRON Gen.2, 100Tests, cobas c, Integra Elecsys ?-Amyloid (1-42) CSF II pTau Elecsys E2G 100 V2 Elecsys Phospho-Tau (181P) CSF pTau Elecsys cobas e60 V2 beta-Amyloid(1-42) G2 Elecsys cobas e 60 beta-Amyloid(1-42) G2 Elecsys E2G 100 ELECSYS INSULIN Elecsys Insulin Assay Insulin Elecsys cobas e 100 Insulin Elecsys E2G 100 Elecsys Insulin cobas MRSA/SA Test cobas 4800 system SW C4800 2.1 MRSA/SA AP V1.1 CD KIT COBAS4800 MIXEDBATCH LYSIS1 240T IVD cobas 4800 MRSA/SA Amplification/Detection Kit, 80 Test cobas 4800 MRSA/SA Amplification/Detection Kit, 240 Tests KIT COBAS 4800 MRSA/SA AMP/DET 80T IVD KIT COBAS 4800 MRSA/SA CONTROLS IVD KIT COBAS 4800 MRSA/SA AMP/DET240T IVD KIT COBAS 4800 MIXEDBATCH INT CTRL 1 IVD cobas 4800 MRSA/SA Controls and Cofactor Kit, 10 Runs KIT COBAS4800 MIXEDBATCH LYSIS1 960T IVD FT4 II Assay Elecsys FT4 G2 CS Elecsys FT4 II CalSet Elecsys FT4 II Assay FT4 II Calibrator FT4 G2 Elecsys cobas e 200 FT4 G2 Elecsys E2G 300 T3 Elecsys E2G 300 FT3 G3 Elecsys E2G 300 T3 Elecsys cobas e 200 V2 FT3 G3 Elecsys cobas e 200 V2 Elecsys FT3 III FT3 G3 Elecsys E2G 300 V2 Elecsys T3 T3 Elecsys E2G 300 V2 COAGUCHEK XS PLUS CARE KIT CoaguChek® XS Plus system Calcitonin Elecsys cobas e 100 V2 Calcitonin Elecsys E2G 100 V2 Elecsys Calcitonin ELECSYS ACTH CALSET ACTH CC3 Elecsys Elecsys ACTH Immunoassay ACTH Elecsys E2G 100 Elecsys ACTH Calset Elecsys ACTH CalCheck ACTH CS Elecsys Elecsys PreciControl ACTH ACTH Elecsys cobas e 100 Elecsys ACTH ACTH CC 3 Elecsys COBAS INTEGRA METHADONE II 200 COBAS INTEGRA ONLINE DAT II METHADONE II BIL-D JK 800Tests cobas c 701, US cobas c 501 D-BILI AMPHETAMINES II ONLINE DAT Amphetamines II AMPS2, 850T, cobas c 503 ISD CC 5 Elecsys cobas e-ELECSYS PreciControl ISD cobas e-ELECSYS FOLATE RBC CS Folate RBC CC 3 Elecsys Folate RBC Elecsys cobas e 100 cobas e-ELECSYS FOLATE RBC Folate RBC CS Elecsys ELECSYS FOLATE RBC CALSET Folate RBC Hemolyzing Elecsys cobas e cobas e-ELECSYS FOLATE RBC HEMOLIYZING ELECSYS FOLATE RBC COAGUCHEK XS PT CONTROLS APO A TQ 100Tests cobas c701 APOAT, 100Tests, cobas c, Integra Tina-quant Apolipoprotein cobas INTEGRA APO A1 Tina-quant Apolipoprotein A-1 ver.2 APOAT, 250T, cobas c 503 Methadone Metabolite Enzyme Immunoassay ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM ELECSYS PRECICONTROL ANTI-HBS Anti-HBs PC Elecsys Anti-HBs Elecsys cobas e Anti-HBs Elecsys cobas e 100 Anti-HBs CC 3 Elecsys Anti-HBs Elecsys E2G 300 H ALP PHOS IFCC LIQ R1 [D,P] Alk Phos ALK PHOS Liquid Propoxyphene cobas PROPOXPH/200 Propoxyphene Reagents PPX, 2x850T, cobas c 503 Propoxyphene Plus Testosterone G2 Elecsys E2G 300 Elecsys Testosterone II Calset Testosterone Gen. 2 Elecsys, cobas e Elecsys Testosterone II Assay & CS Elecsys Testosterone II ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM ACCUCHEK INSTANT PLUS CHOLESTEROL ACCUCHEK INSTANT PLUS GLUCOSE Accutrend Chol, 25T. AccuChek Instant Plus Dual Testing System ACCUTREND PLUS METER ONLY KIT, MG/DL ACCUTREND CHOLESTEROL CONTROL 2 LEVEL HIV, HIV-2+GrpO PC Elecsys PreciControl HIV; HIV-2+GrpO HIV duo Elecsys E2G 300 V2 Elecsys HIV Duo HIV PC G2 Elecsys PreciControl HIV Gen II Solution, pH Buffer 10X SSC Reaction Buffer Concentrate (10X) ULTRA Cell Conditioning Solution (ULTRA CC1) Antibody Diluent Cell Conditioning Solution (CC1) Cell Conditioning Solution (CC2) ULTRA Cell Conditioning Solution (ULTRA CC2) ISH Probe Diluent VENTANA Antibody Diluent with Casein CINtec Wash Buffer (10X) Troponin T STAT Elecsys cobas e 100 V4 Troponin T STAT CS Elecsys V4 Roche Elecsys Troponin T STAT Troponin T Test Roche Elecsys Troponin T Stat (Short Turnaround Time) Elecsys Troponin T STAT Assay Elecsys Troponin T STAT Elecsys Troponin T STAT CS COBAS ELECSYS PROLACTIN II CALSET PRECICONTROL HBA1C PATH PRECICONTROL HBA1C NORM cobas QUINIDINE/75 ONLINE TDM Quinidine ROCHE ONLINE TDM QUINIDINE QUIN2, 100T, cobas c 503 HE4 Elecsys cobas e 100 HE4 Elecsys E2G 100 HE4 PC Elecsys HE4 CC 5 Elecsys HE4 CS Elecsys ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4 ELECSYS HE4 CALCHECK 5 AMH Elecsys E2G 100 AMH Elecsys cobas e 100 AMH CS Elecsys AMH PC Elecsys AMH CC 5 Elecsys TINAQUANT B 2-MICROGLOBULIN ASSAY b-2 MICROGLOBULIN TINA-QUANT a Unisys Tina-quant B 2-Microglobulin RF TINA-QUANT a Modular P large Tina-quant Rheamatoid Factor II TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM PCT Brahms (Roche) Elecsys E2G 100 V2 PCT Brahms (Roche) Elecsys cobas e100 V2 PCT Brahms (Roche) E2G Elecsys 300 V2 Elecsys BRAHMS PCT PreciControl Anti-HBc II Elecsys Anti-HBc II Anti-HBc G2 PC Elecsys Anti-HBc G2 Elecsys cobas e 100 V2 Anti-HBc G2 Elecsys E2G 300 V2 FT4 G4 Elecsys cobas e 200 FT4 G4 Elecsys E2G 300 Elecsys FT4 IV PreciControl Anti-HCV Anti-HCV PC Elecsys Anti-HCV G2 Elecsys cobas e 100 V2 Anti-HCV G2 Elecsys E2G 300 V2 Elecsys Anti-HCV II Anti-HCV G2 Elecsys cobas e 200 V2 COBAS TaqMan HBV Test For Use With The High Pure System COBAS AmpliPrep/COBAS TaqMan HBV Test, version 2 COBAS TAQMAN HBV TEST ELECSYS FT3 Elecsys FT3 Assay FT3 CS Elecsys V2 FT3 Elecsys cobas e 200 V2 FT3 G3 Elecsys cobas e 200 FT3 G3 CS Elecsys FT3 Gen.2 Elecsys,cobas e ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY B-CrossLaps/serum CS Elecsys ELECSYS SERUM IMMUNOASSAY Coaguchek XS Pro Systems PHNY2, 100T, cobas c PHNY2, 200T, cobas c pack green PHNY2, 200T, cobas c ONLINE TDM Phenytoin - Free Phenytoin application PHNY2, 100T, cobas c pack green ELECSYS INSULIN CALSET ELECSYS TSH ASSAY Elecsys TSH TSH Elecsys cobas e 200 C-Peptide Assay Elecsys C-Peptide C-Peptide Elecsys E2G 100 C-Peptide Elecsys cobas e 100 ELECSYS C-PEPTIDE ASSAY cobas PCP/200 Phencyclidine Reagents ONLINE DAT Phencyclidine Plus PCP, 850T, cobas c 503 ONLINE TDM Carbamazepine Gen.4 CARB4 100 Tests, cobas c CARB4, 500T, cobas c 503 KIT COBAS 6800/8800 CMV RMC IVD SW COBAS CMV ASAP CD KIT COBAS 6800/8800 CMV 96T IVD KIT COBAS 58/68/8800 CMV 192T IVD cobas® CMV MYOGLOBIN CONTROL SET MYO Control Set Myoglobin Control TOBR, 150Tests, cobas Integra COBAS-FP REAGENTS FOR TOBRAMYCIN Gentamicin GENT, 200Tests, cobas Integra cobas Integra Gentamicin Elecsys HIV Duo HIV Duo Elecsys E2G 300 V2 ELECSYS PRECICONTROL CALCITONIN ELECSYS CALCITONIN Calcitonin Elecsys E2G 100 Elecsys Calcitonin Calcheck 5 Calcitonin CS Elecsys Elecsys Calcitonin Calset Calcitonin Elecsys cobas e 100 Calcitonin CC 5 Elecsys MTX Calibrator sTfR, 80Tests, cobas c, Integra STFR Control Set Preciset STFR Tina-quant Soluble Transferrin Receptor sTFR, 100T, cobas c 503 TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR Acetaminophen Gen.2 Assay ACET2 Calibrator ACET2 150 Tests, cobas c, Integra 400 ACET2 calibrator Acetaminophen Gen.2 ONLINE TDM Acetaminophen Gen.2 ACET2, 500Tests, cobas c503 Elecsys T4 T4 Elecsys E2G 300 V2 T4 CS Elecsys V2 Elecsys T4 CalSet T4 Elecsys cobas e 200 V3 C4 Gen.2, 150Tests, cobas c 701 cobas INTEGRA C4 C4-2, 150T, cobas c 503 Tina-quant Complement C4 Ver.2 TINA-QUANT COMPLEMENT C4 TEST SYSTEM cobas CT/NG Test, version 2 cobas z480 Analyzer COBAS 4800 Test System cobas METHADONE ONLINE DAT II METHADONE II MDN2, 850T, cobas c 503 CREAJ Gen.2, 700Test, cobas c, Integra Creatinine Jaffe Gen.2 Creatinin Jaffe 400T c111 ROCHE REAGENT FOR CREATININE Elecsys Testosterone II Testosterone G2 Elecsys cobas e 100 V2 Testosterone G2 Elecsys E2G 300 V2 Elecsys CYFRA 21-1 CalCheck 5 Cyfra 21-1 CC5 Elecsys cobas e 411 cobas e 411 SW Install CD version 03-01 MagNA Pure 96 DNA and Viral NA Large Volume Kit MagNA Pure 24 Instrument MagNA Pure LC Instrument cobas x480 Instrument MagNA Pure 96 DNA Tissue Lysis Buffer MagNA Pure 96 External Lysis Buffer MagNA Pure 96 Plate Holder IVD MagNA Pure 96 Bacterial Lysis Buffer MagNA Pure 24 Protocol Set 1 MagNa Pure 96 Reagent Loop Unit IVD MagNa Pure 96 Bottle Rack IVD MagNA Pure 96 Bacterial Lysis Buffer IVD MagNA Pure 96 DNA and Viral NA SV Kit IVD MagNA Pure 24 Protocol Set v1.3 MagNA Pure 96 SW v3.1 MagNA Pure 96 Protocol Set 1 MagNA Pure 24 Protocol Set MagNA Pure 24 Protocols v1.4 MagNA Pure FFPET Buffer Set MagNA Pure 96 System Software Version 3.1.1 MagNA Pure 24 SW 1.1 MagNA Pure 96 Instrument FFPET Isolation Kit PreClean M Elecsys,cobas e MPLC RNA Isol.Tissue Lysis Buffer Refill ProCell M 2x2 L Elecsys,cobas e MagNA Pure LC tNA Isol. Kit HP Ionify SysR S3 cobas i 1x1L MPLC DNA Isol. Kit III (Bacteria) LC FS DNA Master^PLUS HY-Pb, 96 react. MagNA Pure DNA Tissue Lysis Buffer LC Control Kit DNA Ionify SysR CS cobas i 1x1L MPLC Tub Lid (small, medium) dGTP, PCR Grade Cleaner Basisch cobas c111 NucleoMix, 25mmol/l, 0.6 ml, GPR EcoTergent Ionify SysR VB1 cobas i 4x500ml Ionify System Reagent CS (iSysR CS) Ionify System Reagent VB1 (iSysR V1) Ionify AxisSol cobas i 1x500ml Ionify System Reagent S2 (iSysR S2) Ionify Pretreatment Whole Blood (iPTWB) Ionify System Reagent S1 (iSysR S1) LC HSV 1/2 Template DNA LC QC Kit Activator for cobas c,Integra,c111 LC CD Manual complete SW 4.1 dCTP,PCR Grade Di-Na solution COBAS INTEGRA ISE ETCHER 6 x 11ML MPLC Total Nucleic Acid Isolation Kit ECL-LC, BV-DILUENT, 250ml LC Uracil-DNA Glycosylase ISE ETCHER cobas c 111 system LC Control Kit RNA MPLC RNA Isol. Kit High Performance ISE DEPROTEINIZER cobas c 111 system HITACHI ISE 1N KCL ELECT SOLUTION 1L Terminal Transferase,recombinant (8000U) NACl 9% SI Gen.2, cobas c, Integra Sys Wash Elecsys,cobas e cobas Integra Cleaner MPLC mRNA Isol. Kit I - Lysis Buf.Refill CleanCell Elecsys,cobas e HP Viral Nucleic Acid Buffer Set CLEANING SOLUTION 988-4 (125 ML) S.E.T.S. NaOH-D, cobas c HP Viral Nucleic Acid Kit SODIUM ELECTRODE CONDITIONER (125 ML) MPLC mRNA HS Kit RealTime ready RNA Virus Master HP PCR Template Preparation Kit MPLC Waste Bag Universal Diluent 2x36ml Elecsys,cobas e SMS Solution for HIT 917 RINSE ADDITIVE SOLUTION (100x1 ML) ECL-LC, BV-STORE, 250ml Uracil-DNA Glycosylase,Heat-labile,100 U URINE DILUENT (500 ML) MPLC Total NA Isolation Kit-Large Volume ECL-LC, BV-SANITIZE, 100ml Uracil-DNA Glycosylase,Heat-labile,500 U MPLC DNA Isol. Kit I Probe Wash M Elecsys,cobas e cobas C SPECIAL CELL CLEANING SOLUTION ECL-LC, BV-CLEAN Plus, 1000ml MPLC Processing Cartridges PCR-M Elution Buffer 50mM pH 8,1, MBF NaOH-D, cobas c 701 Sample Cleaner 2, cobas 8000 DEPROTEINIZER (125 ML) MPLC DNA Isol. Kit Large Volume SMS, cobas c Sample Cleaner 2, cobas 6000 Cell Check Elecsys,cobas e MPLC Reaction Tip (large) CLEANING SOLUTION FOR AVL COMPACT II SET STREPTAVIDIN PHYCOERYTHRIN 1mL LUO SMS, cobas c 701 GC-RICH PCR System 2.2 KU PCR ENZYME, CUSTOM SQNM dTTP, PCR Grade, 125 umol PCR Buffer (10x) with MgCl2 GPR dUTP, PCR Grade, 25 umol LC FS DNA MasterPLUS HP, 100 ul PCR Enzyme, custom SQNM 1250 units dUTP,PCR Grade Di-Na Solution 4x125 uM LC Capillaries (100 ul) Phosphatase,alkaline(AP),MB Grade(1U/ul) Phosphatase,alkaline(AP),MB grd.(20U/ul) dCTP,PCR Grade Di-Na Solution 4x125 uM ELECSYS SAP BUFFER SAP Test Elecsys,cobas e LIGHTCYCLER MULTIPLEX DNA MASTER, 1000 rx dATP,PCR Grade Di-Na Solution 4x125 uM LightCycler Capillaries 100ul,M-grade dTTP,PCR Grade Di-Na Solution 4x125 uM Cell Wash Solution I/NaOH-D 2x1.9L LIGHTCYCLER MULTIPLEX DNA MASTER, 200 rx dTTP, PCR Grade, 25 umol LC EvoScript RNA Probes Master (200) ultraView Alkaline Phosphatase Red ISH Detection Kit VENTANA HE 600 Coverslip Activator EZ Prep Concentrate (10X) VENTANA HE 600 Cleaning Solution ULTRA LCS (Predilute) BenchMark Special Stains Deparaffinization Solution (10X) MagNA Pure 24 MGP set VENTANA HE 600 Differentiating Solution ISH Amplification Kit VENTANA HE 600 Wash VENTANA HE 600 Bluing LightCycler EvoScript RNA Probes Master, 200 Reactions LightCycler EvoScript RNA SYBR Green Master 200 HybReady Solution Hemolyzing reagent f.TQ HBA1c,cobas c513 LightCycler EvoScript RNA Probes Master, 1000 Reactions LCS (Predilute) LC EvoScript RNA SYBR Green Master 1000 LightCycler EvoScript RNA SYBR Green Master 1000 Special Stains Vapor Extraction System Special Stains Cleaning Kit VENTANA HE 600 Organic Solution VENTANA ISH iVIEWBlue Detection Kit ultraView SISH DNP Detection Kit LC EvoScript RNA SYBR Green Master (200) Special Cell Cleaning Solution, c513 Clean Cell M 2x2L Elecsys, cobas e Antibody Dilution Buffer ISH Peroxidase Inhibitor Special Stains Heavy Metal Extraction System PreClean M G2 2x2L Elecsys E2G RNA Positive Control Probe ultraView SISH Detection Kit MagNA Pure 24 Total NA Isolation Kit VENTANA ISH iVIEWBlue Plus Detection Kit ultraView Red ISH DIG Detection Kit KIT COBAS 6800/8800 HEV 96T CE-IVD Alu Positive Control Probe II ultraView Silver Wash II BenchMark Special Stains Liquid Coverslip ISH Negative Control ProCell M G2 2x2L Elecsys E2G Diluent MultiAssay E2G Diluent Universal E2G VENTANA HE 600 Transfer Fluid Acid wash Solution 2x2 L VENTANA BenchMark Special Stains Wash II S1 RINSE SOLUTION (2 PCS) cobas c 70x KCL/500 mL KIT ELECSYS CLEAN-CELL M 2X2 L Antigen Excess Reagent S3 FLUID PACK A (1 PC) CLEANING KIT for CL- ELECTRODE NaOH-D, 123Tests, cobas c503 Serum Index Gen.2 NACl 9% Dil, cobas c503, 123T PYP, 950T, cobas c 503 Special Cell Cleaning Solution EcoTergent, cobas c503 Special Wash Solution S2 FLUID PACK (1 PC) cobas® Sample Prep Buffer (CSPB) START, 1000T, cobas c 503 Eco Detergent SCCS, 50Tests, cobas c503 Acid Wash Solution Pyridoxal phosphate KIT COBAS PRIME SPEC PRE-EXTRACTION IVD ISE Reference Electrolyte, 2L SMS, cobas c503, 123T Hemolyzing reagent ISE Reference Electrolyte KIT COBAS PRIME PCR MEDIA IVD BASIC WASH 2x2 L NaCl or Sodium Chloride cobas® Specimen Pre-Extraction Reagent (SPER) NACl 9% SI Gen.2, 14500Tests, cobas c503 NaOH-D or Sodium Chloride Detergent cobas® PCR Media A1CD, cobas c 503 cobas® Sample Prep Buffer LC Multiplex RNA Virus Master, 200 LC Multiplex RNA Virus Master, 1000 SARS-CoV-2 Inactivation Solution UTM/VTM KIT COBAS PRIME SAMPLE PREP BUFFER IVD SARS-CoV-2 Inactivation Solution MagNa Pure 96 System Fluid cobas® Specimen Pre-Extraction Reagent cobas omni Utility Channel (192T) KIT COBAS 58/68/88 UTIL CHAN 192T IVD Benchmark Special Stains Cleaning Kit High Pure PCR Template Preparation Kit M-MLV RT, Mutante 3 Digital LightCycler® Partitioning Fluid Digital LightCycler® RNA Master Kit Digital LightCycler® DNA Master Kit High Pure Viral RNA Kit Ionify iPTReag2 cobas i Ionify SysR VB4 cobas i 1x500ml Ionify SysR S1 cobas i 4x500ml DNA AWAY Ionify Mass Axis Solution (iAxisSol) Ionify SysR VB2 cobas i 4x500ml Ionify Deproteinizer iDepro (6x21ML) Ionify Derivatization Reagent 1 (iDR1) Ionify System Reagent VB3 (iSysR V3) Ionify iDIL cobas i Ionify System Reagent S4 (iSysR S4) Ionify System Reagent VB4 (iSysR V4) Ionify SysR VB3 cobas i 4x500ml Ionify System Reagent VB2 (iSysR V2) Ionify iPTWB cobas i Ionify iPTReag1 cobas i HypoCleaner High PureViral Nucleic Acid Kit Ionify Pretreatment 1 (iPT1) Ionify SysR S2 cobas i 1x1L MPLC Greasing Set NaOH-D/Basic Wash 2x1,8 L LC FS DNA Master Hy.Pb, 480 react. cobas c 70X Internal Standard/2000 mL S.T.A.R. LC Multicolor Demo Set MP Bacteria Lysis Buffer dATP,PCR Grade Di-Na solution ISE DEPROTEINIZER cobas integra (6x21ML) ISE Int.Stand. Gen.2, cobas c, Hitachi Ionify System Reagent S3 (iSysR S3) MPLC Sample Cartridges LC Multiplex DNA Master HP Hitergent cobas c701 MPLC RNA Isol. Kit III Tissue NACl 9% Dil, cobas c HP Viral RNA Kit MagNA Lyser Green Beads MPC Nucleic Acid Isolation Kit I Sample Cleaner 1, cobas c Hitergent c311 cobas Integra Cleaner 150Tests MPLC Reagent Tub (small) MPC Nucleic Acid Isol. Kit I Large Vol. NaCL 9% cobas c 111 LightCycler Capillaries (20ul) 5x96 LC FS DNA Master Hy.Pb., 96 react. MPLC Disposable ISE Diluent Gen.2, 2x2 Liter Sample Cleaner 1, cobas 8000 MPLC Waste Bottle MPLC Cartridge Seal NACl 9% SI Gen.2, 3000Tests cobas c701 Elecsys SYSCLEAN MPLC DNA Isol.KitI-Lysis/Bind.Buf.Refill LC EBV Rec Template ProCell Elecsys,cobas e LC DNA Master Hy. Pb, 96 react. Ionify iDR1 cobas i Ionify SysR S4 cobas i 1x1L MPLC Reaction Tip (small) OMNI SOLUTION 2 (4x40 ML) NACl 9% Dil, cobas c 701 ISE Reference Electrolyte 500ML MPLC Reagent Tub (medium) LC RNA Master Hybridization Probes ECL-LC, BV-GLO Plus, 1000ml MPLC Tub Lid Seal S.E.T.S. II Kit High Pure Viral NA Large Volume Kit MPLC DNA Isol. Kit II (Tissue) NaOH-D / Basic Wash Terminal Transferase, recomb. (24 000 U) Diluent MultiAssay Elecsys,cobas e ISE Diluent Gen.2, cobas c, Hitachi dCTP,PCR Grade Di-Na slt cobas Integra NACl Diluent 9 % Ionify Diluent 1 (iDIL1) Ionify Deproteinizer (iDEPRO) MPLC totalNA Isol.Kit-Lysis/Bind.Buf.Ref LC FastStart Master Hyb Probes, M-Grade PCR Buffer without MgCl_2 , 10 x LC RNA Amplification Kit, Hyb. Probes MPLC O-Ring Maintenance Kit CleanCell M 2x2 L Elecsys,cobas e cobas Integra FP Sample Dilution FLUID PACK S2 (1 PC) LC FS DNA Master^PLUS Hy.Pb, 480 react. MagNA Pure Compact RNA Isolation Kit BlankCell Elecsys,cobas e LC DNA Master Hy.Pb, 480 react. LC Strep B PTS1 GPR Acid wash Solution 2x1,8 L Hybridization Wash Buffer Kit Accelerator I 1 x 100ML Ionify Pretreatment 2 (iPT2) T-Uptake Elecsys E2G 100 PRECINORM PRECIPATH PROTEIN C PRECINORM Proteins for USA PRECIPATH Proteins for USA TRSF2, 500T, cobas c 503 [serum] [urine] Tina-quant Transferrin ver.2 TRSF2, 500T, cobas c 503 (serum) (urine) Ceruloplasmin CERU, 200T, cobas c 503 C.F.A.S. LIPIDS LIPIDS CFAS Cfas Lipids 3x1ML Cfas Lipids 5x5ML ELECSYS ANTI-THSR Anti-TSHR Elecsys E2G 300 ELECSYS ANTI-TSHR IMMUNOASSAY COAGUCHEK XS SYSTEM PRODUCTS CoaguChek XS 24 tests USA COAGUCHEK XS PT TEST 2X24 STRIPS Homocysteine 100Tests, cobas c,Integra Homocysteine Calibrator Kit Homocysteine Calibrator Kit 2x3ml Homocysteine Control Kit Hemocysteine cobas C111 Control Kit Homocysteine 200Tests cobas c701,702 Homocysteine, 100Tests, cobas c503 Homocysteine Enzymatic Assay cobas p630 Application Software cobas p 480 Application Software cobas p 480 instrument cobas p 630 instrument cobas p 680 instrument cobas p 680 Application Software cobas® prime Universal Tray cobas® prime Pre-analytical System KIT COBAS PRIME UWRB IVD cobas® prime User Workflow Reagent Bottle (UWRB) cobas® prime Process Plus Module cobas® prime Tip Rack Tray cobas® prime Secondary Tube Tray AVENIO Edge System Ariosa Tecan Library Robot Ariosa Tecan Detection Robot AcfS Detection Robot AcfS Library Robot AcfS L&D Equipment Installation Bundle cobas transfer - RRF Heam,Coag 10 cobas bge link cobas Academy cobas IT 1000 c8100 PXT c8100 CLW c8100 TLJ c8100 SLL c8100 Type Alpha cobas 8100 OBS cobas 8100 ACU c8100 RFX c8100 Model Beta cobas 8100 connection kit cobas 8100 URF . c8100 SCM cobas 8100 RSF c8100 CLO Universal Connection Unit Bulk Loader for cobas p 471 Laser LLD centrifuge unit cobas connection module c8100 Beta c8100 SLR Aliquot Tip Loader cobas 8100 AOB c8100 CRW cobas 8100 BCL turn unit conveyor unit c8100 BCL cobas 8100 Model Alpha cobas 8100 BCL - FBT Modification kit cobas 8100 Signal Tower c8100 BRF Sorting System cobas p312(Kolibri) Bulk Loader Module for p512/612 LASER LLD INCL QSI/TTI cobas p501/p701 c8100 CRO Liquid Level Detection UPGR Kit cobas p701 cobas p 512 System Software cobas p 612 system cobas p671 output unit CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE cobas 8100 RSS Roche cobas Liat Module- IT 1000 Bi-directional driver STD INSTR P671 TTI W/O BC READ UN 115V p501/p701 Systems STD INSTR P471 TTI W/O BC READ UN 115 PComm ver 1.12.11 cobas Infinity v2.2.3 RSD Systems 770-1-CCM-AOB v1.1 VS Systems CCM AOB sw ver 13 cobas Infinity v2.3.3 SW COBAS P 312 VERSION 1.1.1 SW PATCH_P312_1.1.3_UPD.TAR.BZ2 STD INSTR P612 LASER LLD QSI REC w/o CCM Online Adapter 1.5 cobas Infinity v2.3.2 STD INSTR P671 TTI BC READING UN 115V cobas Infinity v2.2.1 COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM RSA Systems cobas8800B cobas p471 STD INSTR P471 TTI BC READING UNIT 115V cobas infinity sw v2.5.3 CLAS Systems cobas infinity MPA Systems cobas Infinity 3rd Party Drivers IT 1000 Operator Data driver ver. 1.1.2 HemoCue 201DM Glu RT module STD INSTR P612 LASER LLD QSI 3HHT CCM 713-2-cobase 8100 v1.5 CoaguChek Link Tier 1 cobas Infinity v2.2 IT 1000- PCOmmunicator .bat file 579-2-RSA Dynamic Interface v1.1 c8100 SW 03-09 cobas Infinity v2.2.2 c8100 Wright Patterson Air Force Base US cobas IT 1000 i-STAT/DE module HemoCue 201DM Glu module Coaguchek Link cobas infinity insights license PComm ver. 1.12.12 with script_1.12.13 MPA EVO Analycer connection Host CIT1k 3.9 CoaguChek Link Tier 2 Comm Server 1.11.3725 BCM for cobas 8100 Driver Framework 3.1.8915 Power Supply Unit cobas Infinity sw v2.5.1 cobas infinity POC IT solutions IT 1000 All in one installer STD INSTR P512 LASER LLD QSI REC w/o CCM cobas infinity core license cobas IT 1000 Operator Sync CoaguChek Link Tier 3 Piccolo Xpress module cobas p 501/ p 701 system software CCM cobas c 513 Connection Unit Linear Buffer Unit HemoCue 201DM Hb module cobas p 501/701 System Software CCM Address Extension Unit Data Innovations Instrument Manager Modular Connection Unit cobas infinity sw v317 Cobas 6000 Connection Unit CONVEYOR 2 Unit CONVEYOR 4 Unit SW c8000 data manager 168 HST Connection Unit Add-On Buffer Unit NAVIFY Remote Monitor OUTPUT UNIT Cobas 8000 Connection Unit CONVEYOR 3 Unit CONVEYOR 1 Unit CCM Bidirectional Interface TURN UNIT cobas Infinity Central Lab CCM Backend Connection Unit cobas 8100 System Software cobas BLIM for p471/p671/BCM cobas BLIM for p512/p612 ConKit cobas BLIM to p x71 B-Gate Interface cobas p 512 system cobas infinity POC CCM Vertical Overhead Conveyor Unit (1m) cobas transfer - RRF Urine 10 CD SYSTEM SW p 612 SP 2.1.1 navify® Lab Operations Accu-Chek Care cobas infinity POC remote access CCM Vertical Turntable Unit Accu-Chek 360° Diabetes Management System Professional CCM Vertical Power Box Unit Universal Connection Module (UCM2) CD SW multilingual_software_2.1.1 CD SYSTEM SW p 512 SP 2.1.1 navify POC Operations Accu-Chek Care (HCP) Kidney KFRE Algorithm navify Quality Control CCM Vertical Elevator Unit Accu-Chek Smart Pix Software cobas transfer - RRF Coag 5 cobas p 501 Post-Analytical Unit cobas p (701) POST ANALYTICAL Anti-HBs PC Elecsys PreciControl Anti-HBs Elecsys Anti-HBs II Anti-HBs G2 Elecsys E2G 300 V2 Anti-HBs G2 Elecsys cobas e 100 V2 ASLO Gen2, 400Tests, cobas c701/702 ASLO Gen2, 200T, cobas c pack green ASLO TQ, 400Tests, cobas c701 cobas C ASLO TQ ASLO TZ, 150Tests, cobas c Tina-quant Apolipoprotein A-1 ver.2 cobas c 70X Antisteptolysin O/400 APOAT, 250T, cobas c 503 Tina-quant Antistreptolysin-O II Rapid Cartridge C (iRapidC) Rapid Cartridge B (iRapidB) Ionify iRapidC cobas i Ionify iHPLC cobas i HPLC Cartridge (iHPLC) Ionify iRapidB cobas i UA2, 1300T, cobas c 503 Uric Acid ver.2 Syphilis PC Elecsys Elecsys Syphilis Syphilis assay PreciControl Syphilis Syphilis Elecsys cobas e 100 Syphilis Elecsys E2G 300 Syphilis PC Elecsys lq proBNP G2 CS Elecsys E2G Elecsys proBNP II Calset PreciControl Cardiac G2 Elecsys V4 proBNP G2 Elecsys E2G 300 Elecsys Precicontrol Cardiac II proBNP G2 Elecsys cobas e 100 PROBNP II CALSET ELECSYS PROBNP II PRECICONTROL CARDIAC II SHBG Elecsys E2G 300 SHBG Elecsys cobas e 100 ELECSYS SHBG CALSET SHBG CS Elecsys ELECYSYS SHBG cobas PROCAINAMIDE/100 PROC2, 100T, cobas c 503 ONLINE TDM Procainamide ONLINE TDM PROCAINAMIDE Anti-HBc Elecsys cobas e 100 V2.1 Anti-HBc G2 Elecsys E2G 300 REFERENCE ELECTROLYTE (1x250 ML) REFERENCE ELECTRODE ISE Reference Electrolyte 300ML H ISE REFERENCE ELECTRODE COBAS INTEGRA OPIATES 300/2000 200T cobas INTEGRA ISE REFERENCE SOL 250ML SW COBAS 6000 INSTALL CD V06-03 System SW Install CD cobas 311 LCP3 cobas 4000 c311 cobas 6000 Tina-quant Complement C3c Ver.2 C3C-2, 150T, cobas c 503 c311 cobas c 311 Internat. CD version 01-11 cobas c 311 Install SW version 01-12 cobas c 311 Lang-Pack_SW01-12_English CMV IgG Elecsys E2G 300 V2 CMV IgG Elecsys cobas e 100 V2 Elecsys CMV IgG Copan MSwab Collection, Transport and Preservation System Elecsys Anti-HBc II Anti-HBc G2 Elecsys E2G 300 V2 Anti-HBc G2 Elecsys cobas e 100 V2 cobas 4800 Cdiff Controls and Cofactor Kit, 10 Runs KIT COBAS 4800 CDIFF CONTROL IVD cobas 4800 Cdiff Amplification/Detection Kit, 240 Tests cobas 4800 Cdiff Amplification/Detection Kit, 80 Tests TINA-QUANT ALPHA-1 ANTITRYPSIN AAT Gen.2, 150Tests, cobas c 701 AAT Gen.2, 100Tests, cobas c, Integra AAT2, 200T, cobas c 503 Tina-quant ?1-Antitrypsin ver.2 ELECSYS CA 19-9 IMMUNOASSAY/CALSET CA 19-9 Elecsys cobas e 100 CA 19-9 CS Elecsys,cobas e CA 19-9 Elecsys,cobas e CA 19-9 Elecsys E2G 300 CA 19-9 CS Elecsys CA 19-9 Elecsys E2G 100 V1 Elecsys Anti-HBc IgM Anti-HBc IgM Elecsys cobas e 100 Anti-HBc IgM Elecsys E2G 300 CO2-L 700Tests cobas c701 cobas c 70X BICARBONATE/700 CO2, 200T cobas c 111 cobas INTEGRA CO2-L GEN.2 250 TEST cobas INTEGRA BICARBONATE LIQUID CO2-L 1100 Tests cobas c701 CO2-L, 250Tests, cobas c503 Bicarbonate Liquid COBAS INTEGRA CARBON DIOXIDE ASSAY AVL 9180 ELECTROLYTE ANALYZER ELECTRODE ISE CHLOR STARLYTE III, [AW] AVL K+ ELECTRODE AVL CA++ ELECTRODE ELECTRODE, ISE, POTASSIUM CALCIUM-ELECTRODE - ALFA WASSERMANN ELECTRODE, ISE, CHLORIDE ELECTRODE, ISE REF, STARLYTE III, [AW] AVL NA+ ELECTRODE REF.-ELECTRODE - ALFA WASSERMANN ELECTROLYTE ANALYZER W/O STARTERKIT 9180 AVL LI+ ELECTRODE SYSTEM, GENERIC, 9180 ELECTRODE, ISE, POTASSIUM, [ALFA W] LITHIUM-ELECTRODE - ALFA WASSERMANN Cl-ELECTRODE- ALFA WASSERMANN POTASSIUM-ELECTRODE - ALFA WASSERMANN ELECTRODE, ISE, SODIUM, [ALFA W] SODIUM-ELECTRODE - ALFA WASSERMANN AVL CL- ELECTRODE B2MG TQ(a), 140Tests cobas c 701/702 B2MG, 150T, cobas c 503 B2MG TQ(a), 140Tests cobas c Tina-quant B2-Microglubulin (serum/plasma application) Tina-quant B2-Microglubulin (urine application) CA 15-3 G2 Elecsys E2G 300 CA 15-3 G2 Elecsys E2G 100 V1 Elecsys CA 15-3 II ELECSYS CA 125 Gen.2 CS Cortisol CS Elecsys ELECSYS CORTISOL TEST SYSTEM Cortisol Elecsys cobas e 100 Cortisol Elecsys cobas e Elecsys Cortisol ELECSYS PRECICONTROL HBEAG ELECSYS® HBEAG HBeAg Elecsys cobas e 100 Elecsys HBeAg HBeAg PC Elecsys PreciControl HBeAg HBeAg Elecsys E2G 300 cobas b 123 SENSOR CART. BG/ISE/GLU/LAC cobas b 123 FLUID PACK 400 TESTS cobas b 123 FLUID PACK COOX 400 cobas b 123 FLUID PACK 700 cobas b 123 FLUID PACK 200 cobas b 123 FLUID PACK COOX 700 Rubella IgM Elecsys E2G 300 Rubella IgM Elecsys, cobas e PreciControl Rubella IgM Elecsys, cobas Elecsys Rubella IgM Control Elecsys Rubella IgM Assay & Control Elecsys Rubella IgM Rubella IgM Elecsys E2G 100 V1 NH3L Gen.2, 200Tests cobas c701/702 Ammonia II NH3L Gen.2, 150Tests cobas c/INT NH3L2, 300T cobas c 503 COBAS INTEGRA AMIKACIN MAB AMIKM, 150Tests, cobas Integra Amikacin MAB Anti-HBe Elecsys cobas e 100 Anti-HBe PC Elecsys Elecsys Anti-HBe PreciControl Anti-HBe Anti-HBe Elecsys E2G 300 Anti-SARS-CoV-2 S CS Elecsys Anti-SARS-CoV-2 S Elecsys cobas e 200 Anti-SARS-CoV-2 S Elecsys E2G 300 Anti-SARS-CoV-2 S CC5 Elecsys Anti-SARS-CoV-2 S PC Elecsys APOB TINA-QUANT a Unisys APO B TQ 150Tests cobas c701 Tina-quant Apolipoprotein B cobas INTEGRA APO B APOBT, 250T, cobas c 503 Tina-quant Apolipoprotein B ver.2 Valproic Acid cobas VALPROIC/200 HITACHI VALPROIC ACID (911,912,917,P) cobas VALPROIC/100 Valproic Acid Reagents VALP2, 500T, cobas c 503 VALP2, 200T, cobas c 503 cobas Liat system KIT COBAS LIAT STREP A 20 PACK W/PIPETT KIT COBAS LIAT STREP A CTL HITACHI THEOPHYLLINE (911/912/917/P) HITACHI THEOPHYLLINE (917/P) cobas C 311 THEOPHYLLINE/100 Online Theophylline ROCHE ONLINE THEOPHYLLINE THEO2, 100T, cobas c 503 ONLINE TDM Theophylline CA 125 G2 CS Elecsys ELECSYS CA 125 II CALSET Elecsys HBsAg Confirmatory Test HBsAg Confirmatory Test Elecsys, cobas e HBsAg G2 Elecsys cobas e 100 HBsAg G2 PC Elecsys Elecsys HBsAgII PreciControl HBsAg II HBsAg G2 Elecsys cobas e 200 HBsAg G2 Elecsys cobas e 100 V2 HBsAg G2 Elecsys cobas e 300 V2 HBsAg Confirmatory Test Elecsys,cobas e HBsAg Auto Confirm PC Elecsys HBsAg G2 confirmatory Elecsys E2G HBsAg G2 Elecsys cobas e 200 V2 Elecsys HBsAg II PreciControl HBsAg Auto Confirm Elecsys HBsAg II Auto Confirm HBsAg Confirmatory Test Elecsys cobas e V2 PCT Brahms (Roche) Elecsys E2G 300 PCT Brahms Elecsys cobas e 100 PCT Brahms (Roche) Elecsys cobas e 100 PCT Brahms Elecsys E2G 300 Anti-Sars CoV-2 Elecsys cobas e 200 Anti-Sars CoV-2 PC Elecsys Anti-Sars CoV-2 Elecsys E2G 300 cobas HIV-1 Specimen preparation reagents (cobas omni reagents) cobas HBV/HCV/HIV-1 Control Kit cobas 6800/8800 Systems cobas NHP Negative Control Kit cobas HIV-1 analysis specific analysis package (ASAP) software KIT COBAS 58/68/8800 HIV 192T IVD cobas® HIV-1 cobas® HBV/HCV/HIV-1 Control Kit cobas® NHP Negative Control Kit KIT COBAS 58/68/8800 NHP NEG RMC IVD KIT COBAS 58/68/8800 HBV/HCV/HIV RMC IVD Elecsys Cortisol III Cortisol III Elecsys E2G 300 cobas C (501) METHAQUALONE/200 MTQL, 200T, cobas c 503 ONLINE DAT Methaqualone ABUSCREEN ONLINE FOR METHAQUALONE cobas i 601 instrument cobas i 601 ELECSYS ANTI-TPO COBAS ELECSYS ANTI-TPO Anti-TPO Elecsys cobas e 100 V3 cobas e-ELECSYS ANTI-TPO GEN.3 Anti-TPO Elecsys E2G 300 AFP Elecsys E2G 300 V2 AFP Elecsys cobas e 200 V2 Elecsys AFP AFP Elecsys E2G 100 V2 AFP Elecsys cobas e 100 V2 Anti-CMV Elecsys E2G 9 x 300 Anti-CMV PC Elecsys Anti-CMV PC Release Elecsys cobas c 701 Creatine Kinase/800 COBAS INTEGRA ANALYZER PRODUCTS COBAS INTEGRA SYSTEM TP Gen.2, 300Tests, cobas c, Integra cobas INTEGRA IRON 2 cobas INTEGRA CANNABINOIDS GEN II cobas TDM T4 CALIBRATOR KIT cobas INTEGRA T-UPTAKE 200 cobas c 70X Iron/750 cobas INTEGRA ALANINE TRANSAMINASE 500 AST 1100Tests cobas c 701 Iron Gen2. 100T c111 THEO, 225Tests, cobas Integra PHNO, 200Tests, cobas Integra PHNY, 200Tests, cobas Integra cobas Integra 400 Plus FRUC, 250Tests, cobas c 701 CARB, 200Tests, cobas Integra cobas INTEGRA BENZODIAZEPINES 200 CK-MB 100T c111 Ethanol Gen.2 cobas C INTEGRA FRUC ETOH2, 850T, cobas c 503 cobas INTEGRA 400 Plus cobas c 70X Total Protein/700 cobas THEOPHYLLINE/100 cobas INTEGRA ETOH GEN II cobas INTEGRA ASPARTATE TRANSAMINASE 500 Fructosamine I PHENCYCLIDINE 200 PHOS Gen.2, 250Tests, cobas c, Integra cobas c 70X Phosphorus/600 CREAJ Gen.2, 1500Test, cobas c701 I BARBITURATES 200 cobas C ASTL/PYP Phospor 100T cobas c 111 FRA, 550T, cobas c 503 ETOH2, 150T, cobas c 503 CREAJ Gen.2, 2500Test, cobas c503 Creatinine Jaffe Gen.2 ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES PTH Elecsys E2G 300 PTH STAT Elecsys cobas e 100 ELECSYS PTH TEST SYSTEM PTH CS Elecsys cobas e-ELECSYS PTH STAT PTH Elecsys cobas e 100 Thyroid autoantibody immunological test system Anti-TSHR Elecsys E2G 300 V2 Elecsys Anti-TSHR Anti-TSHR Elecsys cobas e 100 V2 Anti-TSHR Elecsys E2G 100 V2 KIT COBAS 6800/8800 EBV 192T IVD cobas EBV ASAP 11.1 cobas® EBV KIT COBAS 6800/8800 EBV/BKV RMC IVD cobas® EBV/BKV Control Kit cobas® EBV ASAP version 11.1 MICRO ELECTRODE NA+ MICRO ELECTRODE CA++ AUTO QC MODUL cobas b 221=Roche OMNI S MICRO ELECTRODE PH AVL MSS CASSETTE GLU/LAC/UREA cobas b 221<6>=Roche OMNI S6 system MICRO ELECTRODE CL MSS CASSETTE GLU MICRO ELECTRODE K+ cobas b 221<2>=Roche OMNI S2 system MICRO ELECTRODE PO2 AVL MSS CASSETTE GLU/LAC cobas b 221<4>=Roche OMNI S4 system MICRO ELECTRODE PCO2 AVL cobas b 221 <2> Roche OMNI S2 system MICRO ELECTRODE REF cobas b 221 <6> Roche OMNI S6 system cobas C INTEGRA HDL-C Gen 3 Vancomycin Gen.3 200 Test cobas c ONLINE TDM Vancomycin Gen.3 Vancomycin Gen.3 100 Test cobas c VANC3, 100T, cobas c 503 VANC3, 200T, cobas c 503 UA plus 400T cobas c111 UA Gen.2, 400Tests, cobas c, Integra cobas INTEGRA URIC ACID 2 UA Gen.2, 1000Tests, cobas c701 URIC ACID Roche HL7 LIS Driver Chemstrip 10 Chemstrip 10 SG 100 Str. Chemstrip 2 GP 100 Str. 1 St Chemstrip 2 LN 100 Str. Chemstrip 2 GP Chemstrip 10 UA 100 Str. Chemstrip 10 w/SG ELECSYS AFP CALSET II AFP G2 CS Elecsys V2.1 COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2 COBAS TaqMan HIV-1 Test version 2 For Use With The High Pure System AMPLILINK Software Version 3.4 C.F.A.S. PRODUCTS Cfas HbA1c, 3x2ml C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) C.F.A.S. HBA1C ROCHE TOTAL MYCOPHENOLIC ACID ASSAY Total Mycophenolic Acid cobas INTEGRA TOTAL MPA CONTROL SET Total MPA Reagents cobas MPA cobas INTEGRA TOTAL MPA CALIBRATOR SET MPA, 100Tests, cobas c 503 Mycophenolic Acid cobas z 480 Analyzer KIT COBAS PCR MEDIA UNI SWB 100 PKT IVD cobas CT/NG Test, v2 SW c4800 CT/NG AP V. 2.1 CD Progesterone G3 CS Elecsys Progesterone III CalSet Progesterone G3 CS Elecsys ELECSYS T-UPTAKE ASSAY T-Uptake Elecsys cobas e T-Uptake Elecsys cobas e 200 T-Uptake CS Elecsys Cyfra 21-1 Elecsys E2G 300 Elecsys CYFRA 21-1 cobas e-ELECSYS CYFRA 21-1 cobas e-ELECSYS CYFRA 21-1 CS Elecsys CYFRA 21-1 CalSet Cyfra 21-1 Elecsys cobas e 100 Cyfra 21-1 CS Elecsys V2 ELECSYS PRECICONTROL TUMOR MARKER ELECSYS DHEA-S CALSET DHEA-S CS Elecsys DHEAS CS Elecsys,cobas e ALP IFCC Gen.2, 200T, cobas c111 ALP IFCC Gen.2 S, 200T, cobas c, Int. ALP IFCC Gen.2 L, 400T, cobas c, Int. ALP IFCC Gen.2, 1050Tests cobas c701 Alkaline phosphatase acc. to IFCC Gen.2 ALP2 Alkaline Phosphatase acc to IFCC Gen.2 (1100 tests) ALP2, 1100T, cobas c pack green URISYS 1100 URINE ANALYZER CHEMSTRIP 10 UA TRAY 30 DISP URISYS 1100 URINE ANALYZER US Calibration strip UA CEA Elecsys E2G 300 ELECSYS CEA CEA Elecsys cobas e 200 CEA Elecsys cobas e 100 cobas e-ELECSYS CEA CEA Elecsys,cobas e CERULOPLASMIN CERU 150Tests cobas c 701 cobas INTEGRA CERULOPLASMIN 100 ACCU-CHEK SPIRIT PRECINORM U plus 10x3ML for US PRECIPATH U plus 10x3ML PRECINORM UNIVERSAL PLUS PRECIPATH U plus 10x3ML for US PRECINORM U plus 10x3ML cobas C ALTL/PYP LIDO, 200Tests, cobas Integra AAGP Gen.2, 100Tests, cobas c, Integra HAPT Gen.2, 100Tests, cobas c, Integra Pyridoxalphosphate UIBC 300Tests cobas c 701 cobas INTEGRA HAPTOGLOBIN COBAS INTEGRA REAGENT CASSETTES cobas Integra FP-Calibr. F-Valproinacid TDM FVALP ACID CAL KIT cobas C (111) PYRIDOXAL PHOSPHATE cobas c Integra SALICYLATE 150Tests TDM FPHNY CALIBRATOR KIT cobas INTEGRA SALICYLATE 150 Pyridoxalphosphat Cobas C111 cobas Integra FP-F-Valproinacid Control ALTL/PYP, 275Tests, cobas c UIBC, 100Tests, cobas c, Integra cobas Integra FP-F-Phenytoin Control cobas INTEGRA AAGP GEN. II ASO, 100Tests, cobas Integra Serumproteins T-Standard Serum proteins T-Standard TDM FVALP ACID CTRL KIT VALP, 200Tests, cobas Integra cobas Integra FP-Calibrator F-Phenytoin I PROPOXYPHENE 200 COBAS INTEGRA PROPOXYPHENE 200 AAGP Gen.2, 150Tests, cobas c 701 UIBC, 100T, cobas c 503 Unsaturated Iron-Binding Capacity SALI, 500T, cobas c 503 Salicylate ALTP2, 800T, cobas c 503 ASTP2, 800T, cobas c 503 Alanine Aminotransferase acc. to IFCC II Aspartate Aminotransferase acc. to IFCC II RHEUMATOID FACTORS TEST SYSTEM PRECISET RF Controlset RF II Rheumatoid Factors Broocresol Purple Dye Binding, Albumin cobas c (311,501) ALB BCP 225 TESTS ALB BCP, 225Tests, cobas c 501,311 Albumin BCP ALB BCP 400Tests cobas c701 Elecsys Troponin T Gen 5 STAT CalSet Elecsys Troponin T Gen 5 STAT Assay Troponin PC Elecsys Troponin T Gen5 Elecsys E2G 300 Elecsys Troponin Gen 5 CalCheck 5 Elecsys PreciControl Troponin Troponin T Gen5 CS Elecsys E2G CalSet Troponin T Gen 5 Elecsys Troponin T Gen 5 Troponin T Gen 5 STAT CS Elecsys Troponin T Gen5 STAT Elecsys cobas e 100 Troponin T Gen 5 CC 5 Elecsys Folate G3 Elecsys E2G 300 Folate G3 Elecsys cobas e 100 V2 Elecsys Folate III Assay Elecsys Folate III D-Dimer Calibrator D-DIMER CONTROL I/II Tina-Quant Rheumatoid Factors II TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM Anti-HAV IgM Elecsys cobas e 100 Elecsys Anti-HAV IgM Anti-HAV IgM Elecsys E2G 300 SOL, SODIUM ELECTRODE CONDITION, 125 ML Anti-CCP Elecsys cobas e 100 Elecsys Anti-CCP Products Anti-CCP PC Elecsys cobas e-ELECSYS PRECICONTROL ANTI-CCP Anti-CCP Elecsys E2G 100 cobas e-ELECSYS ANTI-CCP A2M Reagent Kit Toxo IgM Elecsys,cobas e Toxo IgM Elecsys E2G 100 V1 KIT COBAS 6800/8800 SARS-COV-2 192T cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® 6800/8800 Systems KIT COBAS 6800/8800 SARS-COV-2/FLU RMC KIT COBAS 6800/8800 SARS-COV-2 480T KIT COBAS 6800/8800 SARS-COV-2/FLU 384T KIT COBAS LIAT SARS-COV-2/FLU CTL KIT COBAS 6800/8800 SARS-COV-2 RMC cobas® SARS-CoV-2 & Influenza A/B Control Kit cobas® SARS-CoV-2 Quality Control Kit KIT COBAS LIAT SARS-COV-2/FLU cobas® SARS-CoV-2 - 480T KIT C68/88 SARS-COV2 DUO RMC KIT C68/88 SARS-COV2 DUO 192T KIT COBAS 58/68/8800 SARSCOV2FLUV2 192T KIT COBAS 58/68/8800 SARS-COV-2/FLU RMC AFP Elecsys E2G 300 ELECSYS AFP AFP Elecsys cobas e 100 V1.1 ELECSYS AFP GEN 2 RACKPACK AFP Elecsys cobas e 200 PCT Brahms Elecsys cobas e 100 Elecsys Brahms PCT PCT Brahms [Roche] Elecsys E2G 300 ELECSYS FSH CALCHECK FSH CalCheck FSH CC 3 Elecsys TinaQuant Albumin Gen II ALBT2, 500T, cobas c 503 Tina-quant Albumin Gen.2 cobas C (111) ALTL ALT 1100Tests cobas c 701 cobas c 70X ALT/780 Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation ALTP , 450Tests, cobas c503 proBNP G2 STAT Elecsys cobas e 100 V2.1 proBNP G2 Elecsys E2G 300 V2.1 proBNP G2 Elecsys cobas e 100 V2.1 Elecssys proBNP II Immunoassay Elecsys proBNP II STAT Immunoassay Anti-HAV IgM Elecsys, cobas e Elecsys PreciControl Anti-HAV IgM Anti-HAV IgM Elecsys E2G 300 Anti-HAV IgM PC Elecsys Elecsys Anti-HAV IgM Elecsys Anti-HAV IgM and PreciContr MTX, 100T, cobas c pack green ONLINE TDM Methotrexate MTX, 100T, cobas c 501/502 Syphilis Elecsys E2G 20 x 300 Syphilis Elecsys E2G 300 V2 HIV, HIV-2+GrpO PC Elecsys HIV PC G2 Elecsys HIV combi PT Elecsys cobas e 100 V2 HIV combi PT Elecsys cobas e 200 V2 Elecsys HIV combi PT cobas Influenza A/B & RSV Quality Control Kit cobas Liat Influenze A/B & RSV KIT COBAS LIAT INFLUENZA A/B & RSV CTL KIT COBAS LIAT FLU A/B & RSV US-IVD cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System SW USB COBAS LIAT INFLUENZA RSV cobas Liat System cobas Influenza A/B Quality Control Kit for use on the cobas Liat System PLGF Elecsys E2G 100 V2 Elecsys PlG PlGF Elecsys cobas e 100 V2 Elecsys PlGF sFLT1 Elecsys E2G 100 V2 Elecsys sFLT-1 sFLT1 Elecsys cobas e 100 V2 Cystatin C TQ Gen.2, 225T, cobas c,INT Cystatin C TQ Gen.2, 225T, cobas c 701 Tina-quant Cystatin C Gen.2 CYSC2, 250T, cobas c 503 COBAS TaqMan 48 Analyzer Elecsys CEA Calset CEA CS Elecsys V2 ELECSYS T3 T3 CS Elecsys T3 Elecsys cobas e 200 T3 Elecsys cobas e T3 CS Elecsys, cobas e TRIGL, 250Tests, cobas c, Integra cobas c 70X Triglycerides/800 cobas INTEGRA TRIG GPO 250 TRIGL, 800Tests, cobas c701 TG GPO-PAP 200T cobas c111 TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL COBAS INTEGRA ISE SOLUTION 3. 6 x 9,5ML H ISE STD HIGH 10X3ML H ISE STD LOW 10X3ML cobas INTEGRA ISE CAL DIRECT 250 ML ISE CALIBRATOR DIRECT (250 ML) ELECTRODE ISE POTASSIUM COBAS INTEGRA ISE SOL.1. 6 x 17,5 ML Electrode Chloride Cl/ISE (0980) cobas INTEGRA ISE SOLUTION 2 COBAS INTEGRA ISE SOLUTION 2. 6 x 9,5 ML cobas INTEGRA ISE CAL INDIRECT 250 ML ISE Standard low 10x3ML ISE Standard high 10x3ML ISE CALIBRATOR INDIRECT (250 ML) ELECTRODE REFERENCE ISE (0980) ELECTRODE ISE SODIUM Integra Ion Selective Electrode (ISE) Module Elecsys Anti-CMV Elecsys Syphilis VITAMIN B12 IMMUNOASSAY Vitamin B12 G2 CS Elecsys Elecsys Vitamin B12 Vitamin B12 Elecsys cobas e 100 V2 ELECSYS VITAMIN B12 CALSET GEN 2 Vitamin B12 CC 3 Elecsys cobas e-ELECSYS VITAMIN B12 GEN.2 CRP3, 500T, cobas c 503 C-Reactive Proetin Gen.3 CRP3, 500T, cobas c pack green cobas VANCOMYCIN/100 cobas VANCOMYCIN/200 ELECSYS ANTI-HCV IMMUNOASSAY e601 IMMUNOASSAY ANALYZER Anti-HCV Elecsys cobas e 100 Anti-HCV PC Elecsys Elecsys Anti-HCV PC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2008-07-28
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2008-06-12
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2021-09-08
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-07-21
CHW Titrimetric With Edta And Indicator, Calcium Clinical Chemistry Class 2 862.1145 2012-07-24
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2016-12-20
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2016-12-20
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2020-02-13
QKP Coronavirus Antigen Detection Test System. Unknown Class N N/A 2020-12-07
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2009-02-27
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-01-25
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-01-25
JZJ Prealbumin, Antigen, Antiserum, Control Immunology Class 1 866.5060 1998-06-18
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2010-02-15
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2010-02-15
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2009-08-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2009-08-26
LAN Enzyme Immunoassay, N-Acetylprocainamide Clinical Toxicology Class 2 862.3320 2009-02-27
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2008-05-30
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2008-06-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-09
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2008-06-06
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2008-06-06
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2008-06-06
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2008-07-21
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2021-08-23
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2020-04-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-09-05
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2012-09-05
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2015-08-04
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2018-04-05
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2018-04-05
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2018-04-05
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2008-06-04
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2008-06-04
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2008-06-04
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2018-02-28
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2008-05-30
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2008-05-30
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-05-30
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2008-05-30
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2008-05-30
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2008-05-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-05-30
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2025-11-18
OZN C. Difficile Toxin Gene Amplification Assay Microbiology Class 2 866.3130 2017-09-28
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2017-09-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-07-30
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2012-07-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2012-07-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-07-30
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology Class 2 866.6010 2008-07-21
MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions Unknown Class 3 N/A 2008-07-21
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
MAQ Kit, Dna Detection, Human Papillomavirus Unknown Class 3 N/A 2012-11-02
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2008-05-30
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2019-05-14
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2019-05-14
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2019-05-14
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2019-05-14
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2019-05-14
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2019-05-14
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2019-05-14
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2019-05-14
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2019-05-14
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2019-05-14
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-05-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-05-30
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2017-03-22
NDW Assay, Porphyrin, Spectrophotometry, Lithium Clinical Toxicology Class 2 862.3560 2008-04-17
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-04-17
DAD Haptoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5460 2008-07-16
GHH Fibrin Split Products Hematology Class 2 864.7320 2008-07-14
OQO Herpes Simplex Virus Nucleic Acid Amplification Assay Microbiology Class 2 866.3305 2016-10-19
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2017-03-22
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2017-03-22
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-05-03
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2016-05-03
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2008-05-30
MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Microbiology Class 2 866.3170 2016-10-19
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 1990-05-17
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2020-03-30
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2020-03-30
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-05-30
CDX Radioimmunoassay, Total Thyroxine Clinical Chemistry Class 2 862.1700 2008-06-03
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2017-09-05
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-04-05
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2018-01-16
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2018-01-16
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2018-01-16
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2010-12-02
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-06-13
KLB Radioimmunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2009-02-27
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2008-06-06
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2011-05-06
MKW Cyclosporine Clinical Chemistry Class 2 862.1235 2008-07-21
JHY Colorimetric Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2014-05-09
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2012-02-16
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2012-02-16
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-09-05
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2012-09-05
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-06-06
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2008-06-06
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-06-06
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2008-06-06
DAH Gamma Globulin, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-06-06
JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin Immunology Class 2 866.5340 2008-06-06
JHR Radioimmunoassay, Immunoglobulins (D, E) Immunology Class 2 866.5510 2008-05-30
OWD Somatic Gene Mutation Detection System Unknown Class 3 N/A 2016-10-19
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2008-07-21
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2010-07-28
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-03-24
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2008-06-05
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2008-06-05
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2008-06-05
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2008-06-05
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2008-06-05
PQO Anti-Müllerian Hormone Test System Clinical Chemistry Class 2 862.1092 2022-07-07
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2016-08-11
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 2008-06-06
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2009-10-19
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2012-06-12
MYR Test, Donor, Syphilis, Antigens, Treponemal Microbiology Class 2 866.3830 2023-08-16
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2017-08-25
CHP Radioimmunoassay, Estradiol Clinical Chemistry Class 1 862.1260 2008-07-28
DHA System, Test, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2008-05-30
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-05-30
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2008-06-06
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2018-03-01
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-01-26
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2011-05-04
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-05-04
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 1990-05-17
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2019-05-09
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-07-21
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2014-07-21
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2010-05-19
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2010-05-19
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2010-05-19
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2010-05-19
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2010-05-19
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2010-05-19
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2010-05-19
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2010-05-19
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2010-05-19
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2010-05-19
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2010-05-19
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2010-03-01
MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Microbiology Class 2 866.3170 2012-10-24
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2025-01-23
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2025-01-23
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Microbiology Class 2 866.3393 2025-01-23
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2020-02-17
QVP Sars-Cov-2 Serology Test Microbiology Class 2 866.3983 2025-12-18
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2008-05-30
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2008-06-06
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2008-06-06
MLM Enzyme Immunoassay, Tracrolimus Clinical Chemistry Class 2 862.1678 2018-11-28
QSE Alzheimer’S Disease Pathology Assessment Test Immunology Class 2 866.5840 2023-07-20
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2010-09-14
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2010-09-14
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2023-10-05
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-10-05
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2023-10-05
MSW System, Test, Thyroglobulin Immunology Class 2 866.6010 2023-10-05
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2019-05-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2014-11-03
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2014-11-03
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-11-03
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2009-02-27
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-07-21
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2021-10-29
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2010-09-15
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2010-09-15
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2010-09-15
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2010-09-15
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2010-09-15
LAN Enzyme Immunoassay, N-Acetylprocainamide Clinical Toxicology Class 2 862.3320 2010-09-15
CJX Acid Phosphatase, Disodium Phenylphosphate Clinical Chemistry Class 2 862.1020 2010-09-15
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2010-09-15
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2010-09-15
KXS Radioimmunoassay, Methaqualone Clinical Toxicology Class 2 862.3630 2010-09-15
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2010-09-15
DAD Haptoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5460 2010-09-15
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2010-09-15
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2010-09-15
DKJ Colorimetry, Salicylate Clinical Toxicology Class 2 862.3830 2010-09-15
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2010-09-15
DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control Immunology Class 2 866.5550 2010-09-15
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2010-09-15
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2010-09-15
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2010-09-15
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2010-09-15
CHN Immunochemical, Ceruloplasmin Immunology Class 2 866.5210 2010-09-15
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2010-09-15
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2010-09-15
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2010-09-15
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2010-09-15
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2010-09-15
NDW Assay, Porphyrin, Spectrophotometry, Lithium Clinical Toxicology Class 2 862.3560 2010-09-15
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2010-09-15
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2010-09-15
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2010-09-15
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2010-09-15
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2010-09-15
KLB Radioimmunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2010-09-15
LBZ Enzyme Immunoassay, Quinidine Clinical Toxicology Class 2 862.3320 2010-09-15
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2010-09-15
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2010-09-15
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2010-09-15
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2010-09-15
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2010-09-15
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2010-09-15
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2010-09-15
GHH Fibrin Split Products Hematology Class 2 864.7320 2010-09-15
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2010-09-15
DLB Radioimmunoassay, Lsd (125-I) Clinical Toxicology Class 2 862.3580 2010-09-15
DBF Ferritin, Antigen, Antiserum, Control Immunology Class 2 866.5340 2010-09-15
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2010-09-15
OAV Mycophenolic Acid Test System Clinical Toxicology Class 2 862.3840 2010-09-15
JGQ Turbidimetric, Total Protein Clinical Chemistry Class 2 862.1635 2010-09-15
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2010-09-15
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2010-09-15
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2010-09-15
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2010-09-15
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2010-09-15
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2010-09-15
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2010-09-15
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2010-09-15
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2010-09-15
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2010-09-15
KLP Amikacin Serum Assay Clinical Toxicology Class 2 862.3035 2010-09-15
DIP Enzyme Immunoassay, Diphenylhydantoin Clinical Toxicology Class 2 862.3350 2010-09-15
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2010-09-15
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2010-09-15
DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control Immunology Class 2 866.5580 2010-09-15
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2010-09-15
MRR System, Test, Low Density, Lipoprotein Clinical Chemistry Class 1 862.1475 2010-09-15
JMO Ferrozine (Colorimetric) Iron Binding Capacity Clinical Chemistry Class 1 862.1415 2010-09-15
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2010-09-15
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2010-09-15
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2010-09-15
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2010-09-15
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2010-09-15
NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2010-09-15
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2010-09-15
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2010-09-15
DDR Myoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5680 2010-09-15
LAR Enzyme Immunoassay, Procainamide Clinical Toxicology Class 2 862.3320 2010-09-15
DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Clinical Toxicology Class 2 862.3040 2010-09-15
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2008-05-15
CFT Radioimmunoassay, Prolactin (Lactogen) Clinical Chemistry Class 1 862.1625 2008-07-21
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2024-07-18
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2009-02-27
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2013-12-02
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2013-12-02
MZA Test, Equipment, Automated Bloodborne Pathogen Unknown Class N N/A 2016-11-15
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2010-01-27
CJC Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase Clinical Chemistry Class 1 862.1040 1983-06-01
OWD Somatic Gene Mutation Detection System Unknown Class 3 N/A 2020-07-08
MYR Test, Donor, Syphilis, Antigens, Treponemal Microbiology Class 2 866.3830 2024-11-21
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2008-07-22
JHR Radioimmunoassay, Immunoglobulins (D, E) Immunology Class 2 866.5510 2008-06-06
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2018-06-14
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2023-05-03
CGJ Radioimmunoassay, Follicle-Stimulating Hormone Clinical Chemistry Class 1 862.1300 2008-06-06
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2016-06-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2016-04-27
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2016-04-27
MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Microbiology Class 2 866.3305 2022-11-04
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2001-04-23
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2011-07-22
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 Microbiology Class 2 866.3305 2022-11-04
MKT Hepatitis Viral B Dna Detection Microbiology Class 2 866.3174 2016-01-22
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2009-02-27
JLS Radioimmunoassay, Progesterone Clinical Chemistry Class 1 862.1620 1999-09-08
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2010-10-07
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2010-10-07
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-05-30
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2025-06-17
DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Clinical Toxicology Class 2 862.3040 2008-06-03
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2020-02-10
QSE Alzheimer’S Disease Pathology Assessment Test Immunology Class 2 866.5840 2022-12-08
CFP Radioimmunoassay, Immunoreactive Insulin Clinical Chemistry Class 1 862.1405 2000-04-27
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2016-10-19
NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Microbiology Class 2 866.1640 2016-10-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2014-03-07
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2014-03-07
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 1987-07-13
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2026-02-12
JKR Radioimmunoassay, Calcitonin Clinical Chemistry Class 2 862.1140 2026-05-12
CKG Radioimmunoassay, Acth Clinical Chemistry Class 2 862.1025 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-05-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2009-02-27
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2009-11-16
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2010-09-14
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2010-09-14
JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-11-28
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2011-11-03
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2011-11-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-11-03
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2008-05-30
DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control Immunology Class 2 866.5580 2008-05-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2018-12-03
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2018-12-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2026-04-16
LFR Glucose Dehydrogenase, Glucose Clinical Chemistry Class 2 862.1345 2026-04-16
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2008-06-06
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2008-06-06
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2010-02-12
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2009-02-27
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2010-06-02
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2009-07-28
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2009-07-28
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2009-07-28
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2020-05-19
JCC Ph Buffer Pathology Class 1 864.4010 2010-06-28
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2011-04-07
LBZ Enzyme Immunoassay, Quinidine Clinical Toxicology Class 2 862.3320 2009-02-27
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2012-10-23
OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4) Immunology Class 2 866.6010 2012-10-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-10-23
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-01-09
PQO Anti-Müllerian Hormone Test System Clinical Chemistry Class 2 862.1092 2017-01-09
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-01-09
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2008-06-06
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-05-30
PRI Procalcitonin Assay Microbiology Class 2 866.3215 2020-03-26
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2017-09-25
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2017-09-25
CEC Radioimmunoassay, Free Thyroxine Clinical Chemistry Class 2 862.1695 2023-04-19
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-01-10
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology Class 2 866.3169 2023-01-10
MKT Hepatitis Viral B Dna Detection Microbiology Class 2 866.3174 2012-10-24
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2008-06-04
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-06-04
JMM Column Chromatography & Color Development, Hydroxyproline Clinical Chemistry Class 1 862.1400 2008-06-06
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2010-06-04
MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) Clinical Toxicology Class 2 862.3350 2023-08-03
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-06-03
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2008-06-03
JKD Radioimmunoassay, C-Peptides Of Proinsulin Clinical Chemistry Class 1 862.1135 2008-06-12
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2009-02-27
KLT Enzyme Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2016-04-27
PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology Class 2 866.3180 2017-06-12
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-06-06
LFW Fluorescence Polarization Immunoassay, Tobramycin Clinical Toxicology Class 2 862.3900 2010-03-11
LCQ Fluorescent Immunoassay Gentamicin Clinical Toxicology Class 2 862.3450 2009-11-13
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2023-04-11
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-12-12
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2013-12-12
JKR Radioimmunoassay, Calcitonin Clinical Chemistry Class 2 862.1140 2013-12-12
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2024-02-29
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2008-05-30
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2015-07-22
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2015-07-22
CDX Radioimmunoassay, Total Thyroxine Clinical Chemistry Class 2 862.1700 2021-07-13
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-05-30
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2013-02-14
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2013-02-14
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2013-02-14
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2009-02-27
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2010-02-12
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2022-05-12
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-01-12
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2003-01-28
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2012-05-17
PPM General Purpose Reagent Pathology Class 1 864.4010 2001-03-06
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2017-03-22
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-07-21
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2008-05-30
CHN Immunochemical, Ceruloplasmin Immunology Class 2 866.5210 2020-02-13
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-05-30
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-07-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-07-29
GJS Test, Time, Prothrombin Hematology Class 2 864.7750 2008-05-30
LPS Urinary Homocystine (Nonquantitative) Test System Clinical Chemistry Class 2 862.1377 2012-10-30
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2012-10-30
JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2012-10-30
JQW Station, Pipetting And Diluting, For Clinical Use Clinical Chemistry Class 1 862.2750 2002-04-17
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2008-06-12
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2024-08-02
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2024-08-02
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 1998-11-25
DPM Columns, Liquid Chromatography Clinical Chemistry Class 1 862.2260 2025-06-26
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2020-02-17
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Microbiology Class 2 866.3830 2016-10-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-10-14
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2008-05-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-05-30
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Clinical Chemistry Class 1 862.1680 2011-07-13
LAR Enzyme Immunoassay, Procainamide Clinical Toxicology Class 2 862.3320 2009-02-27
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2011-07-13
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2011-07-13
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2008-05-30
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2008-05-30
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2008-05-30
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2008-05-30
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-05-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-05-30
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2008-05-30
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-05-30
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2008-05-30
LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Microbiology Class 2 866.3175 2022-11-14
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2022-11-14
JTW System, Transport, Aerobic Microbiology Class 1 866.2900 2016-03-23
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2026-04-16
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2026-04-16
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2016-10-19
OZN C. Difficile Toxin Gene Amplification Assay Microbiology Class 2 866.3130 2016-10-19
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer Immunology Class 2 866.6010 2008-05-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2026-04-16
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2026-04-16
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2008-07-18
JIH Flame Photometry, Lithium Clinical Toxicology Class 2 862.3560 2010-02-16
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2010-02-16
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2010-02-16
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2010-02-16
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2010-02-16
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2018-11-19
MOI System, Test, Immunological, Antigen, Tumor Immunology Class 2 866.6010 2018-07-06
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2015-02-19
NHG Enzyme Immunoassay, Cortisol, Salivary Clinical Chemistry Class 2 862.1205 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2014-05-06
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2012-06-08
GGZ Oxyhemoglobin Hematology Class 2 864.7500 2012-06-08
KHG Whole Blood Hemoglobin Determination Hematology Class 2 864.7500 2012-06-08
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2012-06-08
GLY Oximeter To Measure Hemoglobin Hematology Class 2 864.7500 2012-06-08
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2012-06-08
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2012-06-08
GKA Abnormal Hemoglobin Quantitation Hematology Class 2 864.7415 2012-06-08
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2012-06-08
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2012-06-08
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2012-06-08
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2012-06-08
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2012-06-08
LFX Enzyme Linked Immunoabsorbent Assay, Rubella Microbiology Class 2 866.3510 2010-06-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-06-08
JIF Enzymatic Method, Ammonia Clinical Chemistry Class 1 862.1065 2019-03-08
LGJ Fluorescence Polarization Immunoassay, Amibacin Clinical Toxicology Class 2 862.3035 2008-06-06
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2021-03-08
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology Class 2 866.3173 2021-03-08
QKO Reagent, Coronavirus Serological Unknown Class N N/A 2020-04-23
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control Immunology Class 2 866.5600 2008-05-30
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2009-02-27
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Microbiology Class 2 866.2680 2016-10-19
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2009-02-27
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-05-30
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology Class 2 866.3172 2017-01-05
PRI Procalcitonin Assay Microbiology Class 2 866.3215 2018-07-11
NTM Antigen, Inflammatory Response Marker, Sepsis Microbiology Class 2 866.3210 2018-07-11
PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens Microbiology Class 2 866.3215 2018-07-11
QVP Sars-Cov-2 Serology Test Microbiology Class 2 866.3983 2025-07-03
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2016-10-19
JFT Fluorometric, Cortisol Clinical Chemistry Class 2 862.1205 2025-07-21
KXS Radioimmunoassay, Methaqualone Clinical Toxicology Class 2 862.3630 2009-02-27
DOP Mass Spectrometer, Clinical Use Clinical Chemistry Class 1 862.2860 2025-06-26
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2008-05-30
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Immunology Class 2 866.6010 2022-10-17
MZE Test, Donor, Cmv Unknown Class 2 N/A 2023-11-21
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2010-03-01
LGS Fluorescence Polarization Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2008-05-30
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-05-30
DEL Lipoprotein X, Antigen, Antiserum, Control Immunology Class 1 866.5590 2008-05-30
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2008-05-30
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2008-05-30
LGI Fluorescence Polarization Immunoassay, Carbamazepine Clinical Toxicology Class 2 862.3645 2008-05-30
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2008-05-30
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2008-05-30
JXO Enzyme Immunoassay, Cocaine Clinical Toxicology Class 2 862.3250 2008-05-30
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2008-05-30
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2008-05-30
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2008-05-30
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2008-05-30
DDG Transferrin, Antigen, Antiserum, Control Immunology Class 2 866.5880 2008-05-30
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2008-05-30
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-05-30
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-05-30
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2008-05-30
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2008-05-30
CET Olive Oil Emulsion (Turbidimetric), Lipase Clinical Chemistry Class 1 862.1465 2008-05-30
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2008-05-30
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2008-05-30
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2008-05-30
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2008-05-30
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2008-05-30
MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) Clinical Toxicology Class 2 862.3350 2008-05-30
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-05-30
DLZ Enzyme Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2008-05-30
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-05-30
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2008-05-30
LGQ Fluorescence Polarization Immunoassay, Phenobarbital Clinical Toxicology Class 2 862.3660 2008-05-30
DIH Colorimetry, Cholinesterase Clinical Toxicology Class 1 862.3240 2008-05-30
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2008-05-30
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2008-05-30
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-05-30
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2008-05-30
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2008-05-30
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2008-05-30
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2008-05-30
JZW Nephelometer Immunology Class 1 866.4540 2008-05-30
JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2008-05-30
DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Clinical Toxicology Class 2 862.3040 2008-05-30
LBZ Enzyme Immunoassay, Quinidine Clinical Toxicology Class 2 862.3320 2008-05-30
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2008-05-30
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2008-05-30
LPT System, Test, Urinary Methylmalonic Acid Clinical Chemistry Class 2 862.1509 2008-05-30
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 2008-05-30
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2008-05-30
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2008-05-30
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2008-05-30
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2008-05-30
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2008-05-30
KXT Enzyme Immunoassay, Digoxin Clinical Toxicology Class 2 862.3320 2008-05-30
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2008-05-30
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2008-05-30
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2008-05-30
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2008-05-30
LAR Enzyme Immunoassay, Procainamide Clinical Toxicology Class 2 862.3320 2008-05-30
LAN Enzyme Immunoassay, N-Acetylprocainamide Clinical Toxicology Class 2 862.3320 2008-05-30
CFN Method, Nephelometric, Immunoglobulins (G, A, M) Immunology Class 2 866.5510 2008-05-30
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2008-05-30
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2008-05-30
CEW Radioimmunoassay, Parathyroid Hormone Clinical Chemistry Class 2 862.1545 2008-05-30
JZO System, Test, Thyroid Autoantibody Immunology Class 2 866.5870 2020-03-19
QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna Microbiology Class 2 866.3183 2020-08-12
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2010-02-16
KHG Whole Blood Hemoglobin Determination Hematology Class 2 864.7500 2010-02-16
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2010-02-16
GGZ Oxyhemoglobin Hematology Class 2 864.7500 2010-02-16
KHP Acid, Lactic, Enzymatic Method Clinical Chemistry Class 1 862.1450 2010-02-16
CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2010-02-16
GGF Acid Hematin Hematology Class 2 864.7500 2010-02-16
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry Class 2 862.1120 2010-02-16
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2010-02-16
GHS Assay, Carboxyhemoglobin Hematology Class 2 864.7425 2010-02-16
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2010-02-16
JFP Electrode, Ion Specific, Calcium Clinical Chemistry Class 2 862.1145 2010-02-16
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2008-06-04
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2016-10-06
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2010-03-11
OUG Medical Device Data System General Hospital Class 1 880.6310 2014-03-05
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2008-08-13
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2008-08-13
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2008-08-13
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2008-08-13
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2008-08-13
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2008-08-13
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2008-08-13
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2008-08-13
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2008-08-13
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2008-08-13
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2016-10-19
KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology Class 2 864.8165 2008-07-21
LAS Drug Specific Control Materials Clinical Toxicology Class 1 862.3280 2009-02-27
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2009-02-27
OAV Mycophenolic Acid Test System Clinical Toxicology Class 2 862.3840 2009-02-27
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2016-10-19
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2016-10-19
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2016-10-19
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2015-10-07
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-06-03
KHQ Radioassay, Triiodothyronine Uptake Clinical Chemistry Class 2 862.1715 2008-06-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-12-15
OVK Cytokeratin Fragments 21-1 Eia Kit Immunology Class 2 866.6010 2016-12-15
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-12-15
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-05-30
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2008-05-30
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2008-07-22
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2008-07-22
DHX System, Test, Carcinoembryonic Antigen Immunology Class 2 866.6010 2008-06-06
CHN Immunochemical, Ceruloplasmin Immunology Class 2 866.5210 2008-05-30
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2012-07-02
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-05-30
JHN Turbidimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 2008-06-03
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2008-06-03
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2008-06-03
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2008-06-03
LEG Enzyme Immunoassay, Valproic Acid Clinical Toxicology Class 2 862.3645 2008-06-03
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-06-03
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2008-06-03
KXS Radioimmunoassay, Methaqualone Clinical Toxicology Class 2 862.3630 2008-06-03
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2008-06-03
LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control Immunology Class 1 866.5420 2008-06-03
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 2008-06-03
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2008-06-03
KLP Amikacin Serum Assay Clinical Toxicology Class 2 862.3035 2008-06-03
JGJ Photometric Method, Magnesium Clinical Chemistry Class 1 862.1495 2008-06-03
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2008-06-03
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2008-06-03
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2008-06-03
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2008-06-03
DKJ Colorimetry, Salicylate Clinical Toxicology Class 2 862.3830 2008-06-03
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot Clinical Chemistry Class 2 862.1100 2008-06-03
DAD Haptoglobin, Antigen, Antiserum, Control Immunology Class 2 866.5460 2008-06-03
DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control Immunology Class 2 866.5130 2008-06-03
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2008-06-03
MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) Clinical Toxicology Class 2 862.3350 2008-06-03
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2008-06-03
KLR Enzyme Immunoassay, Lidocaine Clinical Toxicology Class 2 862.3555 2008-06-03
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2008-06-03
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2008-05-30
CJW Bromcresol Purple Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2009-02-27
MMI Immunoassay Method, Troponin Subunit Clinical Chemistry Class 2 862.1215 2017-01-26
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-01-26
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2017-01-26
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2017-01-26
CGN Acid, Folic, Radioimmunoassay Clinical Chemistry Class 2 862.1295 2015-09-24
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2008-05-30
GHH Fibrin Split Products Hematology Class 2 864.7320 2008-05-30
LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology Class 2 866.3310 2026-04-16
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2026-04-16
KEM Agent, Clearing Pathology Class 1 864.4010 2010-06-28
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2010-02-12
NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) Immunology Class 2 866.5775 2008-09-17
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-09-17
DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control Immunology Class 2 866.5620 2018-04-11
LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii Microbiology Class 2 866.3780 2017-07-11
QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown Class N N/A 2020-04-23
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer Immunology Class 2 866.6010 2008-06-06
PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens Microbiology Class 2 866.3215 2016-08-04
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-08-04
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2009-02-27
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2010-09-24
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 2008-06-12
NBC Test, Natriuretic Peptide Clinical Chemistry Class 2 862.1117 2022-04-28
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-07-02
LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology Class 2 866.3310 2010-07-02
LAO Enzyme Immunoassay, Methotrexate Unknown Class U N/A 2024-02-29
MYR Test, Donor, Syphilis, Antigens, Treponemal Microbiology Class 2 866.3830 2025-12-16
MZF Test, Hiv Detection Microbiology Class 2 866.3956 2017-07-20
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2016-10-19
OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2016-10-19
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2016-10-19
QWH Prognostic Test For Development Or Progression Of Preeclampsia Clinical Chemistry Class 2 862.1602 2025-04-03
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2017-02-07
JJF Analyzer, Chemistry, Micro, For Clinical Use Clinical Chemistry Class 1 862.2170 2008-06-06
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-07-21
CDP Radioimmunoassay, Total Triiodothyronine Clinical Chemistry Class 2 862.1710 2008-06-04
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2008-06-04
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides Clinical Chemistry Class 1 862.1705 2010-02-12
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2008-07-21
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2008-07-21
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 2008-07-21
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 2008-07-21
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 2008-07-21
MYR Test, Donor, Syphilis, Antigens, Treponemal Microbiology Class 2 866.3830 2025-12-01
CDD Radioassay, Vitamin B12 Clinical Chemistry Class 2 862.1810 2008-05-30
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2008-05-30
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2008-05-30
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2009-04-22
LEH Radioimmunoassay, Vancomycin Clinical Toxicology Class 2 862.3950 2009-02-27
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology Class 2 866.3169 2013-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Frazier Business: Roche Diagnostics Operations Inc Email: brian.frazier@roche.com Phone: (317) 5214603

Related Public Records

Same Entity

Roche Diagnostics Operations Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Other Registrations for Same Entity

Registration Number Establishment Name Location
3010900203 Roche Diagnostics S.L. Sant Cugat del Valles Barcelona, ES
3039321686 Roche Lumira Dx Stirling Manor Loan Stirling, GB
3039322300 Roche Lumira Dx Bathgate Bathgate Scotland, GB
3011806823 Roche Diabetes Care GmbH Mannheim Baden-Wurttemberg, DE
3020917535 Roche Diagnostics (Suzhou) Ltd. Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K861663 Data Medical Associates, Inc. TOTAL PROTEIN PROCEDURE 1986-06-13
K832169 Sandare Chemical Co., Inc. TOTAL PROTEIN PROCEDURE 1983-08-16
K771476 Instrumentation Laboratory CO MULTISTAT III TOTAL PROTEIN TEST 1977-09-12
K200509 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Vitamin D Total (VitD) 2020-05-29
K041905 Instrumentation Laboratory CO HEMOSIL CALIBRATION PLASMA 2004-09-28

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ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
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Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
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ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

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