Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2517506

FEI Number

2517506

Entity Name

SIEMENS HEALTHCARE DIAGNOSTICS INC.

City/State/Country

NEWARK, DE, US

Establishment Address

500 GBC DR, PO Box 6101, NEWARK, DE 19714, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)

Owner / Operator Contact Address

Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K981801

PMA Number

N/A

All Registered Proprietary Names

Dimension IRON Flex Emit 2000 Phenytoin Assay Stratus CS Acute Care MYO TestPak Stratus CS Acute Care CKMB TestPak Stratus CS Acute Care CTNI CalPak Stratus CS Acute Care CKMB CalPak Stratus CS Acute Care CTNI TestPak Stratus CS Acute Care MYO CalPak Dimension TOBR Flex Atellica CH Tobramycin (Tob) Emit Ethyl Alcohol Cal Emit Ethyl Alcohol Negative Cal Emit Ethyl Alcohol Low Control Emit Ethyl Alcohol High Control Emit 2000 N-Acetylprocainamide Assay Emit tox Serum Tricyc Antidep Cal Emit tox Serum Tricyc Antidep Assay Emit 2000 Procainamide Assay Dimension Drugs of Abuse Pos Ctrl ADVIA® Chemistry Toxicology Controls Dimension Drugs of Abuse Neg Ctrl Dimension LOCI Free Thyroxine Flex reagent cartridge (LOCI FT4L) Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (LOCI TSHL) Dimension Vista CO2 Flex Dimension EXL 200 integrated chemistry system Dimension EXL with LM and STM Ready Dimension EXL with LM integrated chemistry system Dimension Vista Progesterone Calibrator Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2, Level 3, Level 4 Emit II Plus Specialty Drug Control Negative Emit II Plus Specialty Drug Control Positive Emit Cal/Controls Levels 0-5 Dimension LOCI Anemia Calibrator Dimension LOCI Vitamin B12 Flex Emit II Plus Barbiturate Assay Syva RapidTest d.a.u. 5 mAMP/OPI/COC/THC/PCP Emit II Plus Ethyl Alcohol Assay Emit II Plus Methaqualone Assay Atellica CH Enzymatic Creatinine_2 (ECre_2) Emit 2000 Carbamazepine Assay Dimension/Dimension Vista Enzyme Diluent Dimension Vista ALB Flex Dimension Vista CRBM Flex Dimension Vista TIBC Flex Dimension Vista AST Flex Atellica CH IMT Standard A (IMT Standard A) Atellica CH Reagent Probe Cleaner 1 (RPC1) Atellica CH 930 Analyzer Atellica CH Cleaner Atellica CH EMPTY Atellica CH Reagent Probe Cleaner 4 (RPC4) Atellica CH Lamp Coolant (LC) Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge) Atellica CH Water Bath Additive (WBA) Atellica CH IMT Diluent (IMT Diluent) Atellica Direct Load Atellica CH Reagent Probe Cleaner 2 (RPC2) Atellica CH Diluent Atellica CH IMT Dilution Check (IMT Dilution Check) Atellica CH Check Reagent (CHK) Atellica CH Albumin BCP Calibrator (AlbP CAL) Atellica CH Wash Atellica CH Conditioner Atellica CH EMPTY1 Atellica CH HA1c_E High Volume Labels (50) Atellica CH EMPTY2 Atellica CH HA1c_E High Volume Bottles (5) Atellica CH HA1c_E High Volume Conversion Kit Atellica CH Lid Keying Feature Atellica CH 930 Analyzer (Fully Refurbished) Syva RapidTest d.a.u. 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP Vista DIGXN Flex Emit 2000 Phenobarbital Assay Dimension C3 Flex Dimension Vista TU Flex MAGIC LITE T UPTAKE REFERENCE SERUM Dimension C4 Flex ADVIA Chemistry Albumin BCP (ALBP) ADVIA Chemistry Albumin BCP CAL (ALBP CAL) Atellica CH Digoxin (Dgn) Stratus CS Acute Care DDMR CalPak Stratus CS Acute Care DDMR TestPak Dimension Vista FOL Flex Dimension Vista MYO Cal Dimension Vista MYO Flex Vista ENZ 6 Cal Atellica CH Diazo Direct Bilirubin (D_DBil) Syva Emit Methotrexate Assay Dimension SAL Flex Emit 2000 Valproic Acid Assay Dimension Vista Testosterone Calibrator Dimension Vista Total Testosterone Flex reagent cartridge Atellica CH Carbon Dioxide, Concentrated (CO2_c) ADVIA ADVIA Chemistry Emit 2000 Tobramycin Calibrators Emit 2000 Tobramycin Assay Emit 2000 Quinidine Assay Syva Emit 2000 Mycophenolic Acid Assay Dimension MPAT Flex Atellica CH Mycophenolic Acid (MPA) Dimension MPAT Cal Dimension MPAT Flex (DF215) Dimension FT4 Flex SCS MYO CalPak SCS MYO TestPak Atellica CH DRUG CAL (DRUG CAL) Dimension Drug Cal Dimension UCFP Flex Dimension FERR Cal QuikLyte IMT Flush Solution QuikLyte IMT Diluent Check QuikLyte IMT Sample Diluent Dimension BARB Flex Vista LH Flex MAGIC LITE LH LUTEN Emit II Plus Benzodiazepine Assays Atellica CH Benzodiazepines (Bnz) Atellica CH Benzodiazepines (BnzC) ADVIA Chemistry Stratus CS DDMR TestPak Dimension CCRP Flex Dimension MMB Cal Stratus CS BHCG TestPak Stratus CS BHCG CalPak Emit 2000 Tacrolimus Sample Pretrea Atellica CH Tacrolimus Emit 2000 Tacrolimus Assay Atellica CH Direct Bilirubin 2 (DBil_2) ADVIA ADVIA Chemistry DBIL_2 IMMULITE 2000 T4 (TT4) Dimension T4 Flex Dimension Vista® CHK Flex® reagent cartridge Dimension Vista® Urea Nitrogen Flex® reagent cartridge V-Lyte Standard B Dimension Vista® Phenobarbital Flex® reagent cartridge Dimension Vista® Empty Flex® reagent cartridge Dimension Vista® Sample Probe Cleaner Dimension Vista® Cuvette Wash Solution Dimension Vista® Mass CKMB Isoenzyme Calibrator Dimension Vista® Small Sample Container (SSC) Dimension Vista® Reagent Probe Cleaner Dimension Vista® Aliquot Plates V-Lyte Dilution Check Dimension Vista® Barcode Labels V-Lyte Standard A V-Lyte Diluent V-Lyte Integrated Multisensor Dimension Vista® System Diluent Dimension Vista® Cuvettes Dimension Vista® Sample Cups Dimension Vista® Empty Vials Kit Dimension Vista® System (500, 1000T, 3000T) Dimension Vista® LOCI Reaction Vessels Dimension COC Flex Dimension LNTP Flex Dimension NTP Flex Emit Amikacin Assay Dimension OPI Flex Dimension ACTMN Flex Syva Emit 2000 Mycophenolic Acid Calibrators Syva RapidTest d.a.u. MDN Emit II Plus Phencyclidine Assay Dimension CCRP Cal Stratus CS Acute Care CCRP CalPak Dimension Vista AFP Flex Dimension Vista UDAT CON (Pos) Dimension Vista UDAT Con (Neg) Emit 2000 Procainamide Assay Emit 2000 Procainamide Cals Atellica CH Theophylline (Theo) Dimension THEO Flex Emit II Plus Opiate Assays Atellica CH Opiates (Op) Atellica CH Opiates (OpC) Dimension LIDO Flex Atellica CH LIDO Assay Dimension Vista HDLC Flex Emit 2000 Digoxin Assay Emit II Plus Oxycodone Positive Control 300 Emit II Plus Oxycodone Negative Control 100 Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 Emit II Plus Oxycodone Negative Control 300 Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 Emit II Plus Oxycodone Positive Control 100 Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 Dimension DGTX Flex Dimension LOCI N-Terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge Dimension Vista LOCI B-type Natriuretic Peptide Flex reagent cartridge ADVIA Centaur NT-proBNP (PBNP) Atellica IM NT-proBNP (PBNP) Dimension Vista LOCI 7 Calibrator Dimension Vista LOCI CA 19-9 Flex VITROS Chemistry Products CAFFN Reagent Kit BOX/200T ADVIA Chemistry Cystatin C_2 Calibrator Atellica CH Cystatin C Calibrators (CysC CAL) Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL) Dimension Vista Chemistry 1 Calibrator Atellica CH Toxicology Calibrator (TOX CAL) Dimension Vista Thyroxine/Thyronine-Uptake Calibrator Atellica CH Special Chem CAL (SPCL CHEM CAL) Atellica CH Liquid Specific Protein Calibrators (LSP CAL) Atellica CH Protein 2 Calibrator (PROT2 CAL) Dimension VANC Flex Vista LOCI 8 Calibrator Atellica CH Ecstasy (XtcC) Emit II Plus Ecstasy Assay Atellica CH Ecstasy (Xtc) Dimension T/F PSA Cal Vista FPSA Flex Dimension FPSA Flex Emit Caffeine Assay Emit 2000 Quinidine Assay Emit 2000 Quinidine Cals Atellica CH Iron3 (Iron_3) Dimension TP/ALB Cal Emit 2000 Gentamicin Plus Cals Emit 2000 Gentamicin Plus Assay Syva RapidTest d.a.u. BZO Dimension® Phosphorus Flex® reagent cartridge Emit Cal B Level 1 (cutoff) Emit Cal B Level 2 (high) Vista LA Flex Atellica CH Lac_3 EDMS Software System Dimension CRBM Flex Atellica CH Carbamazepine (Carb) Dimension FT3 Flex MAGIC LITE T3 100 TEST KIT IMMULITE 2000 Total T3 (T3) Dimension Vista FT3 Flex Dimension LOCI VITD Cal Dimension LOCI Vitamin D Total Assay Atellica CH A-LYTE IMT Cleaner Dimension Vista® Acid Clean Flex® reagent cartridge Emit Caffeine Control Dimension Vista BHCG Cal Dimension Vista BHCG Flex Dimension PHNO Flex Atellica CH Phenobarbital (Phnb) Emit 2000 Tacrolimus Cal Dimension Vista PCHE Flex Dimension Vista URCA Flex Dimension Vista PROC Flex Dimension Vista SAL Flex Dimension Vista TRIG Flex Dimension Vista TOBR Flex Dimension Vista PHOS Flex Dimension Vista GGT Flex Dimension Vista CHOL Flex Dimension Vista AMY Flex Dimension Vista T4 Flex Dimension Vista VALP Flex Dimension Vista ACTM Flex Dimension Vista GLU Flex Dimension Vista LDLC Flex Dimension Vista LIDO Flex Dimension Vista VANC Flex Dimension SAL Cal Dimension Everolimus Calibrator Dimension UCFP Cal Ictotest Dimension TGL Flex Atellica CH Triglyceride_2 (Trig_2) Dimension PALB Flex Dimension Vista CEA Flex Emit Primidone Assay Emit II Plus Buprenorphine Assay Emit II Plus Propoxyphene Assay Syva Emit II Plus 6-Acetylmorphine Cals/Controls Level 1-4 Syva Emit II Plus 6-Acetylmorphine Assay VITROS Chemistry Products Calibrator Kit 11 box/1 set/6 btls Syva RapidTest d.a.u. 3 THC/COC/OPI Dimension THY Cal Dimension SIRO Cal Dimension SIRO Flex Aptio Automation System Dimension Empty Flex Dimension Small Sample Container Dimension ALDL Flex Dimension TP Flex Dimension Vista A1AT Flex Atellica CH Alpha-1-Antitrypsin 2 (AAT2) Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 Atellica CH DRUG CAL II Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 Syva RapidTest d.a.u. COC Dimension Vista THEO Flex Dimension Vista DGTX Flex Dimension Vista PTN Flex Dimension Vista GENT Flex Dimension ECO2 Flex Dimension Vista LOCI 1 Cal Dimension IGG Flex Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Atellica Rack Handler Atellica CI Reaction Cuvette Segments Atellica CI Dilution Cuvette Segments Atellica CI Analyzer; (Model 1900) Atellica CH Albumin BCP (AlbP) Atellica Direct Connect for CI VITROS Chemistry Products CAL KIT 26 IMMULITE 2000 Phenobarbital (PHE) IMMULITE 2000 Systems Diluent Tube Caps Atellica CH A-LYTE IMT Cleaner IMMUUTE 2000 Systems Microsampling Tubes IMMULITE 2000 Systems Allergen Tube Septum IMMULITE 2000 Systems Reaction Tubes IMMULITE 2000 Systems Diluent Tubes IMMULITE 2000 XPi System Sample Cup Nesting IMMULITE 2000 Chemiluminescent Substrate Module IMMULITE 2000 Systems Allergen Tube Caps IMMULITE 2000 Systems Microsampling Tube Caps IMMULITE 2000 XPi Immunoassay System IMMULITE 2000 Immunoassay System Emit Cal Level 0 (Neg) Dimension AMM Flex Atellica CH Ammonia (Amm) ADVIA Chemistry Total Bilirubin_2 (TBIL_2) Atellica CH Total Bilirubin_2 (TBIL_2) Clinitek Novus Pro 12 Atellica Japan Enzymatic Creatinine (ECreJ) Pack Dimension THC Flex Emit 2000 Cyclosporine Specific Asy Emit tox Serum Calibrators (Negative, Low, and Medium) Dimension Vista Lipase Flex ADVIA Chemistry Lipase Dimension Lipase Flex Atellica CH Protein 1 Calibrator (PROT1 CAL) Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL) Atellica CH Bilirubin Calibrator (BILI CAL) Emit 2000 Phenobarbital Assay Emit 2000 Phenobarbital Cals Dimension FOL Flex Dimension B12 Flex Atellica IM NT proBNPII (PBNPII) ADVIA Centaur NT proBNPII (PBNPII) Dimension ENZ 1 Cal Dimension HCG Flex Dimension LHCG Flex Dimension Vista DBIL Flex Atellica CH Barbiturates (BrbC) Atellica CH Brb SCS Rotors SCS Cannula (BD) SCS Cannula (Sarstedt) SCS Printer Paper SCS Sample Cup SCS Pipette Tips SCS Cannula (Terumo) Stratus CS Analyzer SCS Waste Bin Liner ADVIA Chemistry ALP_2 Calibrator Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL) Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) Dimension ALPI Calibrator Dimension ALPI Flex Emit 2000 Theophylline Cals Emit 2000 Theophylline Assay Dimension Vista ENZ 1 Cal Emit 2000 Theophylline Assay Dimension PALB Cal Stratus CS Acute Care CCRP TestPak Emi II Plus Methadone Assays Atellica CH Methadone (Mdn) Atellica CH Methadone (MdnC) Vista Enzyme 2 Calibrator Atellica CH Cannabinoids THC (ThcC) Emit II Plus Cannabinoid Assays Atellica CH Cannabinoids THC (Thc) Dimension Vista TIBC Cal Dimension PCHE Verifier ADVIA Chemistry Atellica CH Alanine Aminotransferase (ALT) Dimension Vista ALTI Flex Dimension ALTI Flex Atellica CH Alanine Aminotransferase P5P (ALTPLc) SCS CKMB DilPak Emit 2000 Cyclosporine Neg Cal Emit 2000 Cyclosporine Specific Asy Emit 2000 Cyclosporine Specific Cal Emit 2000 CSA Sample Pretreat Rgt Dimension CTNI Cal Atellica CH Oxycodone (OXYC) Emit II Plus Oxycodone Assay Atellica CH Oxycodone Assay Dimension Vista Oxycodone (OXY) Flex Reagent Cartridge Dimension Oxycodone (OXY) Flex Reagent Cartridge Dimension Vista CHEM 4 Cal Atellica CH HDL Cholesterol (HDLC) Atellica CH LDL Cholesterol (LDLC) Dimension PROC Flex Atellica CH Procainamide (PROC) Emit 2000 Phenytoin Assay Emit 2000 Phenytoin Cals Atellica CH Lactate Dehydrogenase L-P (LDLP) Dimension LDI Flex DM Vista LDI ADVIA Chemistry LDLP ADVIA Chemistry LDPL ADVIA Chemistry LAC Dimension Vista Creatinine Flex Reagent Cartridge (CRE2) Vista DGTX Cal Emit 2000 Vancomycin Assay Dimension EXTC Flex Emit tox Acetaminophen Calibrators Emit tox Acetaminophen Assay Advia Centaur with StreamLAB Dimension MBI Flex Dimension CKI Flex Dimension CKI-MBI Cal Dimension Everolimus Assay POCcelerator UniPOC CentraLink RAPIDComm Atellica Data Manager (ADM) Atellica® Connect SE Atellica® Connect EDM eDM Lite Stratus CS D-Dimer TestPak DDMRE Emit II Plus Methadone Assay Syva RapidTest d.a.u. mAMP Emit II Plus Amphetamines Assay Dimension IGM Flex ADVIA Chemistry Emit II Plus Ethyl Alcohol Assays Atellica CH Gamma-Glutamyl Transferase_2 (GGT_2) Dimension IRON Cal Dimension Enzyme II Cal ADVIA Chemistry Salicylate (SAL) Atellica CH Salicylate (Sal) Atellica CH Salicylate (SalC) Dimension LOCI Thyroid Cal Dimension PTN Flex Atellica CH Phenytoin (Phny) Atellica CH Diazo Total Bilirubin (D_TBil) Atellica® CH N-acetylprocainamide (NAPA) Dimension NAPA Flex Dimension LI Flex Emit 2000 Carbamazepine Cals Emit 2000 Carbamazepine Assay Dimension LOCI B-type Natriuretic Peptide Calibrator Dimension Vista LOCI B-type Natriuretic Peptide Calibrator Dimension CSA Flex Dimension MALB Flex Dimension MALB Cal Dimension Vista TBIL Flex Syva RapidTest d.a.u. THC Dimension Vista FERR Flex Vista FSH Flex IMMULITE® 2000 FSH IMMULITE® 2000 FSH Sample Diluent IMMULITE® / IMMULITE® 1000 FSH Dimension IBCT Flex Dimension TRNF Flex Dimension TBI/DBI Cal Dimension TBI Flex Dimension DBI Flex Dimension HCG Cal Atellica CH A1c_EZ PRE Atellica CH Enzymatic Hemoglobin A1c (A1c_E) ADVIA Chemistry A1c_E Reagent (4x300 Kit) ADVIA Chemistry A1c_E Pretreatment Buffer Kit ADVIA Chemistry A1c_E Reagent (2x150 Kit) Syva RapidTest d.a.u AMP Emit tox Serum Benzodiazepine Assay QuikLYTE IMT Std A QuikLyte IMT Std B Dimension Sample Cups with Lids Dimension CA Flex Dimension BUN Flex Dimension CHEM I Cal Purified Water Diluent Dimension Enzyme Verifier Dimension Cuvette Cartridge Dimension Salt Bridge Solution Syva RapidTest d.a.u. OPI Emit II Plus Opiate Assay Dimension Vista PREALB Flex N Antiserum to Human Prealbumin Atellica CH Prealbumin (PALB) Emit II Plus Cocaine Metabolite Assay ADVIA Chemistry Enzyme 2 Calibrator (ENZ 2 CAL) ADVIA Chemistry ADVIA Chemistry Enzyme 1 Calibrator (ENZ 1 CAL) Atellica CH ENZ 1 Calibrator (ENZ 1 CAL) Atellica CH ENZ 2 Calibrator (ENZ 2 CAL) ADVIA Chemistry Enzyme 3 Calibrator (ENZ 3 CAL) Dimension PCP Flex Emit 2000 Siro/Tacro Sample Pretrea Emit 2000 Sirolimus Calibrators Emit 2000 Sirolimus Assay Dimension IGA Flex SCS CKMB CalPak Emit 2000 Digoxin Cals Dimension LA Flex Dimension Sample Probe Cleaner Dimension Reagent Probe Cleaner Dimension Reaction Vessels Dimension® HM Dimension IMT Probe Cleaner Dimension FERR Flex Dimension Chemistry Wash Dimension Sample Diluent Atellica CH A-LYTE Integrated Multisensor (IMT Na K CI) Emit LSD Assays Emit LSD Control Level II Emit LSD Control Level I Emit LSD Cals (10 ml) Atellica IM 1600 Analyzer Atellica IM Cleaner Atellica IM Wash Atellica IM Acid/Base Atellica IM 1300 Analyzer Atellica IM Acid Atellica IM Ancillary Seal Kit Atellica IM Base Atellica IM 1300 Analyzer (Fully Refurbished) Atellica IM 1600 Analyzer (Fully Refurbished) Atellica CH Creatinine_3 (Crea3) Aliquot Wheel Assembly Dimension Creatinine Flex reagent cartridge VITROS Chemistry Products Calibrator Kit 14 box/1 set/6 btls Vista LOCI 4 Cal Vista VB12 Flex Dimension Vista TSH Flex Dimension Vista FT4 Flex Dimension Vista/EXL MULTI 2 SDIL Dimension Vista® Magnesium Flex® reagent cartridge Dimension Vista Estradiol Flex (E2) Dimension Vista Multi 1 Sample Diluent (MULTI 1 SDIL) Dimension DGNA Flex Atellica CH Cholinesterase_2 (CHE_2) Dimension Chemistry III Calibrator Atellica CH CHEM III Calibrator (CHEM III CAL) ADVIA Chemistry Atellica CH Total Iron Binding Capacity (TIBC) Atellica CH A1c_3 Calibrator (A1c_3 CAL) ADVIA Chemistry HbA1c Denaturant Reagent (HbA1c Denat) Dimension TPSA Flex Vista TPSA Flex Atellica CH Phencyclidine (Pcp) Assay Atellica CH Vancomycin (Vanc) Assay Atellica CH Phencyclidine (PcpC) Emit II Plus Benzodiazepine Assay Dimension CTNI Flex Dimension LTNI Flex Dimension AHDL Flex Dimension/Dimension Vista CTNI Sample Diluent Dimension TNI Flex Dimension Vista CTNI Sample Diluent Emit tox Salicylic Acid Assay Emit tox Salicylic Acid Calibrators Emit 2000 Digoxin Assay VITROS Chemistry Products Calibrator Kit 13 box/1 set/6 btls Emit 2000 N-Acetylprocainamide Cals Emit 2000 N-Acetylprocainamide Assy Dimension AHDL Cal Dimension Vista ETOH Flex Vista Prolactin Flex (LOCI PRL) Emit Antiepileptic Drug Cal Set Stratus CS CTNI CalPak Atellica CH Chemistry Calibrator (CHEM CAL) ADVIA Chemistry Lithium_2 (LITH_2) Atellica CH Lithium_2 (LITH_2) Emit 2000 Vancomycin Cals Dimension LIPL Cal Dimension CSA Cal Dimension RCRP Cal Dimension TU Flex Dimension T4 Cal Dimension URCA Flex Dimension TU Cal Dimension CHK Flex Dimension T4 Flex Emit tox Serum Barbiturate Assay Syva RapidTest d.a.u. TCA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2007-11-15
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2007-11-15
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-11-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-15
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2007-11-27
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2007-11-16
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2007-11-15
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-11-15
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2007-11-15
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2019-07-02
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2025-08-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2025-08-19
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2007-11-15
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-11-15
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-11-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-04-25
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2013-04-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-04-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2015-11-09
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2015-11-09
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2015-11-09
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-11-27
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2007-11-27
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2014-01-10
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-01-10
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2007-11-27
DNI	Liquid Chromatography, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-09-05
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-09-05
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-09-05
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2007-11-15
KXS	Radioimmunoassay, Methaqualone	Clinical Toxicology	Class 2	862.3630	2007-11-15
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-01-07
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2007-11-15
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2007-11-15
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2007-11-15
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2007-11-15
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2007-11-15
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2017-05-16
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2017-05-16
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-05-16
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2017-05-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-05-16
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2017-05-16
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-05-16
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-09-05
DKN	Radioimmunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2017-09-05
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-09-05
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-09-05
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-09-05
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-09-05
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-09-05
LAG	High Pressure Liquid Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-09-05
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2017-09-05
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2017-09-05
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2010-05-10
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2010-05-10
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2007-11-15
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-11-27
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	1998-03-12
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-11-27
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2013-12-12
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-12-12
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2008-01-07
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-11-15
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2007-11-15
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2007-11-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-11-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-04-02
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2023-06-30
LAO	Enzyme Immunoassay, Methotrexate	Unknown	Class U	N/A	2013-05-06
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2007-11-16
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-02-24
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2016-02-24
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2010-06-08
KLB	Radioimmunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2007-11-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2007-11-14
LDO	Enzymatic Radiochemical Assay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2007-11-14
LBZ	Enzyme Immunoassay, Quinidine	Clinical Toxicology	Class 2	862.3320	2007-11-15
OAV	Mycophenolic Acid Test System	Clinical Toxicology	Class 2	862.3840	2010-06-23
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-01-26
OAV	Mycophenolic Acid Test System	Clinical Toxicology	Class 2	862.3840	2012-01-26
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2007-11-27
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-11-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-15
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2007-11-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-11-27
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-11-27
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-11-27
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-11-27
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-11-14
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1995-04-18
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-11-27
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2007-11-15
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-11-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-14
MLM	Enzyme Immunoassay, Tracrolimus	Clinical Chemistry	Class 2	862.1678	2007-11-15
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-06-28
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2018-02-20
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-11-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-15
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-15
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2007-11-15
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2007-11-15
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-11-15
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-11-15
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-11-15
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2007-11-15
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-11-15
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-11-15
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2007-11-15
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2007-11-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-11-14
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2008-10-21
KLQ	Radioimmunoassay, Amikacin	Clinical Toxicology	Class 2	862.3035	2007-11-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-11-14
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2007-11-27
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2010-11-16
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-09-05
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-11-15
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-15
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Immunology	Class 2	866.6010	2009-05-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-11-15
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2007-11-24
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2011-09-22
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2011-09-22
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2011-09-22
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-11-27
KLR	Enzyme Immunoassay, Lidocaine	Clinical Toxicology	Class 2	862.3555	2007-11-15
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2007-11-15
JHM	Colorimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2008-08-01
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-27
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2018-05-16
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2007-11-27
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2014-04-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-04-22
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2011-04-22
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-01-18
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2013-01-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-08-03
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2007-11-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-08-06
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-11-15
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2007-11-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2007-11-15
MTG	Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	Unknown	Class 3	N/A	2007-11-27
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2007-11-15
LBZ	Enzyme Immunoassay, Quinidine	Clinical Toxicology	Class 2	862.3320	2007-11-24
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2022-02-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-24
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2007-11-27
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-09-05
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2016-05-02
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2007-11-27
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2006-08-01
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2007-11-19
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2007-11-27
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1998-02-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-04-06
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2017-04-06
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2001-08-18
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-11-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-11-15
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2007-11-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2007-11-15
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-15
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2007-11-15
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2007-11-15
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2007-11-15
KLR	Enzyme Immunoassay, Lidocaine	Clinical Toxicology	Class 2	862.3555	2007-11-15
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2007-11-15
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2007-11-15
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2007-11-15
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2007-11-15
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2007-11-15
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2007-11-15
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2007-11-15
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2007-11-15
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2007-11-15
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2007-11-15
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-11-15
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2007-11-15
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2007-11-15
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2007-11-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2007-11-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2021-04-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-24
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2012-07-26
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2007-11-15
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2007-11-14
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2008-08-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-08-01
DJD	Enzyme Immunoassay, Primidone	Clinical Toxicology	Class 2	862.3680	2007-11-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-08-01
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-08-01
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2007-11-15
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2011-03-29
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2011-03-29
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2011-03-29
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-01-18
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2013-01-18
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-01-18
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-09-05
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-09-05
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-09-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
NRP	Sirolimus Test System	Clinical Toxicology	Class 2	862.3840	2008-12-10
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2008-12-10
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2007-11-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-11-14
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-11-14
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-11-14
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2007-11-14
KLB	Radioimmunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2007-11-14
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2007-11-14
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-11-14
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-11-14
DMJ	Test Reagents For Ethyl Alcohol	Clinical Toxicology	Class 2	862.3040	2007-11-14
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2007-11-14
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2007-11-14
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2007-11-14
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2007-11-14
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2007-11-14
CKE	Acid Phosphatase, Thymolphthale Inmonophosphate	Clinical Chemistry	Class 2	862.1020	2007-11-14
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-11-14
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2007-11-14
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-14
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2007-11-14
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-11-14
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2007-11-14
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2007-11-14
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2007-11-14
JHM	Colorimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2007-11-14
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2007-11-14
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2007-11-14
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2007-11-14
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-11-14
JHC	Acid, Uric, Uricase (Oxygen Rate)	Clinical Chemistry	Class 1	862.1775	2007-11-14
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-11-14
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-11-14
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2007-11-14
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2007-11-14
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2007-11-14
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2007-11-14
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2007-11-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2007-11-14
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2007-11-14
KLR	Enzyme Immunoassay, Lidocaine	Clinical Toxicology	Class 2	862.3555	2007-11-14
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-11-14
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2007-11-14
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2007-11-14
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2007-11-14
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-11-14
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-11-14
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2007-11-14
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-14
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2007-11-14
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2007-11-14
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-11-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-11-14
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2007-11-14
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2007-11-14
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-11-14
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2007-11-14
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2007-11-14
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-11-14
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2007-11-14
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2007-11-14
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2007-11-14
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2007-11-14
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-11-14
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2007-11-14
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2007-11-14
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2007-11-14
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2007-11-14
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-11-14
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2007-11-14
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-14
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2007-11-14
JHT	Chromatographic Separation, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-14
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-11-14
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2007-11-14
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2007-11-14
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-11-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-11-24
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2007-11-15
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2007-11-27
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2007-12-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2007-12-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-04
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2024-01-25
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-01-25
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2018-05-16
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-09-05
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2007-11-15
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2007-11-15
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-15
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2007-11-15
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2007-11-15
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2007-11-15
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-11-14
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-11-27
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2023-07-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-07-20
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2023-07-20
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2013-01-18
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-01-18
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-01-18
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-05-19
JHR	Radioimmunoassay, Immunoglobulins (D, E)	Immunology	Class 2	866.5510	2009-05-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2009-05-19
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2009-05-19
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2009-05-19
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2007-11-16
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2013-02-27
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2017-05-10
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2017-05-10
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-05-23
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-11-14
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2007-11-15
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-06-24
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2007-11-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2023-04-10
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2007-11-19
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2010-02-19
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2010-02-19
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2024-01-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-10-21
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-11-27
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-11-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-11-15
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-27
CJO	Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2012-08-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-08-01
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2007-11-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-15
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-11-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-11-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-02-21
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2007-11-27
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-11-15
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2007-11-16
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2002-05-07
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2007-11-27
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2007-11-27
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2007-11-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-11-08
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-11-15
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2024-08-19
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2024-08-19
LAR	Enzyme Immunoassay, Procainamide	Clinical Toxicology	Class 2	862.3320	2007-11-15
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2007-11-19
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2002-05-07
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2014-01-29
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-01-21
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2007-11-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-11-15
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2007-11-14
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2007-11-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-04-02
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2009-04-02
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-10-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-10-21
JHS	Differential Rate Kinetic Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-10-21
OUF	Everolimus Immunoassay	Clinical Toxicology	Class 2	862.3840	2021-04-05
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2000-02-07
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2011-05-20
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-11-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-09-05
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-11-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-11-15
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-11-27
DML	Nad-Nadh, Specific Reagent For Alcohol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2007-11-27
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2023-06-16
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-02-21
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2010-06-08
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-05-10
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2007-11-19
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2026-06-12
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2026-06-12
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2007-11-15
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2007-11-15
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2007-11-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-11-16
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-11-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-09-05
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2011-01-21
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2007-11-27
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-11-27
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-11-15
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JIW	Calibrator, Surrogate	Clinical Chemistry	Class 2	862.1150	2007-11-27
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2021-07-19
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2021-07-19
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-09-05
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-11-16
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-11-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-09-05
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-11-15
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2003-01-16
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-11-08
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2016-02-09
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2007-11-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2009-04-02
NRP	Sirolimus Test System	Clinical Toxicology	Class 2	862.3840	2009-04-02
CFQ	Radioimmunoassay, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2007-11-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-24
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2007-11-19
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2007-11-27
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2023-08-01
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2023-08-01
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2023-08-01
DLB	Radioimmunoassay, Lsd (125-I)	Clinical Toxicology	Class 2	862.3580	2007-11-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-06-16
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-06-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-06-16
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2025-01-15
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-11-14
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2014-02-17
LDO	Enzymatic Radiochemical Assay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2013-01-18
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-01-18
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-01-18
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2013-02-15
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-15
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2014-12-03
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2014-12-03
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2015-06-16
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2015-06-16
NDR	Enzyme Immunoassay, Inhibin-A	Clinical Chemistry	Class 1	862.1260	2011-04-22
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-24
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2022-05-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-04-25
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2008-01-09
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2011-06-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-06-28
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2007-11-27
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2007-11-27
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2023-08-11
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2023-08-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-11-15
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-11-14
JHM	Colorimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2008-03-12
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2008-08-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2007-11-15
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2007-11-15
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2007-11-15
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-01-18
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2013-01-18
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-01-18
LAN	Enzyme Immunoassay, N-Acetylprocainamide	Clinical Toxicology	Class 2	862.3320	2007-11-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2007-11-15
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1995-04-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-15
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Clinical Toxicology	Class 2	862.3560	2008-01-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-01-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-09
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-10-21
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2007-11-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-11-27
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-11-16
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-11-15
LFI	High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-09-05
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-09-05
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-09-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012817228	Epocal Inc	Ottawa Ontario, CA
3011194542	Siemens Healthcare GmbH	Berlin, DE
3009448641	Siemens Healthcare Diagnostics, Inc.	Mishawaka, IN, US
3004959793	EPOCAL, INC.	Ottawa Ontario, CA
9610633	SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD	SUDBURY Suffolk, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K905689	Microgenics Corp.	CEDIA PHENYTOIN ASSAY	1991-01-17
K171566	Siemens Healthcare Diagnostics, Inc.	Atellica IM High-Sensitivity Troponin I (TNIH)	2018-07-19
K182225	Siemens Healthcare Diagnostics, Inc.	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	2019-03-04
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	BC Thrombin Reagent . Thrombin Time Test
Z-0017-2014	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0030-2013	Siemens Healthcare Diagnostics, Inc.	2	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Z-0031-2012	Siemens Healthcare Diagnostics, Inc.	1	Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
Z-0038-2012	Siemens Healthcare Diagnostics, Inc.	1	Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.
Z-0039-2017	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Z-0069-2012	Siemens Healthcare Diagnostics, Inc.	1	Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Z-0089-2023	Siemens Healthcare Diagnostics, Inc.	1	Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Z-0121-2011	Siemens Healthcare Diagnostics, Inc.	1	EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Z-0127-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista HbA1c
Z-0134-2021	Siemens Healthcare Diagnostics, Inc.	2	Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Z-0148-2015	Siemens Healthcare Diagnostics, Inc.	2	siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

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3005094123	ABBOTT IRELAND DIAGNOSTICS DIVISION	Longford, IE
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2517506. Last updated year: 2026. Please use registration number 2517506 when referencing this establishment in official correspondence.