Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005333358

FEI Number

3005333358

Entity Name

ABBOTT LABORATORIES

City/State/Country

Lake Forest, IL, US

Establishment Address

Conway Park, 675 North Field Drive, Lake Forest, IL 60045, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARCHITECT Progesterone Manual Diluent (LN 7K77-50) ARCHITECT Progesterone Reagent Kit (LN 7K77-25, 7K77-35) Alinity i Progesterone Reagent Kit (LN 08P3620, 08P3630) Alinity i Progesterone Manual Diluent Kit (LN 08P3640) ARCHITECT iValproic Calibrators (LN 1P35-01) ARCHITECT iValproic Reagent Kit (LN 1P35-25) Urine/CSF Protein Calibrator (LN 1E71-02) Iron/Magnesium Calibrator (LN 1E69-03) Bilirubin Calibrator (LN 1E66-04) Lipase Calibrator (LN 3E16-02) Carbon Dioxide Calibrator (LN 1E64-02) Architect iDigoxin Reagent Kit (LN 1P32-27) Architect iDigoxin Calibrators (LN 1P32-02) ARCHITECT C-Peptide Reagent Kit (LN 3L53-27) Alinity i C-Peptide Reagent Kit (LN 09P3620) ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit (LN 2R98-25, 2R98-35) Quinidine (LN 06L3120) Quinidine Calibrators (LN 06L3101) ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37) Alinity i BRAHMS PCT Reagent Kit (LN 01R1821) ARCHITECT BRAHMS PCT Controls (LN 6P22-10) ARCHITECT BRAHMS PCT Calibrators (LN 6P22-01) Alinity c Ethanol Control Kit (LN 08P4110) Immunalysis Ethyl Glucuronide Controls Ethyl Alcohol Urine Control Set ARCHITECT HBsAg Qualitative Controls (LN 4P53-10) ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01) Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (LN 08P1141) Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (LN 08P1121) Alinity i HBsAg Qualitative II Reagent Kit (LN 08P1021, 08P1031) Alinity i HBsAg Qualitative II Controls (LN 08P1012) ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit (LN 4P54-25) Alinity i HBsAg Qualitative II Calibrators (LN 08P1002) ARCHITECT HBsAg Qualitative Reagent Kit (LN 4P53-25, 4P53-35) ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent (LN 4P54-40) ARCHITECT Folate Manual Diluent (LN 1P74-50) ARCHITECT Folate Reagent Kit (LN 1P74-27, 1P74-37) Alinity i Folate Reagent Kit (LN 08P1421, 08P1431) Alinity i Folate Manual Diluent (08P1460) ARCHITECT Folate Calibrators (LN 1P74-02) ARCHITECT Folate Controls (LN 1P74-12) ARCHITECT ANTI-HCV REAGENT KIT (LN 1L79-25, 1L79-35) ARCHITECT ANTI HCV CALIBRATOR (LN 1L79-01) ARCHITECT ANTI-HCV CONTROLS (LN 1L79-10) Alinity i Anti-HCV Reagent Kit (LN 08P0521) Alinity i Anti-HCV Controls (LN 08P0510) Alinity i Anti-HCV Calibrator (LN 08P0501) Alinity c Apolipoprotein B Reagent Kit (LN 09P4720) Apolipoprotein B (Alinity c, LN 09P4724) Apolipoprotein B (ARCHITECT, LN 09D9324) APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22) Quantia ASO Control II (LN 6K55-22, 6K55-23) Multichem A1c ARCHITECT System Accessories ARCHITECT System Amikacin Calibrators - LN 06L3501 ASPARTATE AMINO TRANSFERASE (AST) (LN 7D81-21) Alinity hq Processing Module (LN 09P6801) Alinity hs Processing Module (LN 09P6901) TOX Controls - LN 06L3610 Alinity i Anti-TPO Reagent Kit (LN 09P3521) ARCHITECT Anti-TPO Calibrators (LN 2K47-01) ARCHITECT Anti-TPO Reagent Kit (LN 2K47-27) ARCHITECT Anti-TPO Controls (LN 2K47-10) ARCHITECT Total T4 Calibrators (LN 7K66-01) ARCHITECT Total T4 Controls (LN 7K66-10, 7K66-12) ARCHITECT Total T4 Reagent Kit (LN 7K66-25, 7K66-30, 7K66-35, 7K66-27, 7K66-32, 7K66-37) Alinity i Total T4 Reagent Kit (LN 07P9520, 07P9530) ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22) ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42) Alinity c Alanine Aminotransferase Reagent Kit (LN 07P9820) Alinity c Activated Alanine Aminotransferase Reagent Kit (LN 08P1820) Alanine Aminotransferase2 (Alinity c; LN 04T8420, 04T8430) Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824) Alanine Aminotransferase2 (ARCHITECT; LN 04S8820, 04S8830) Activated Alanine Aminotransferase (ARCHITECT, LN 08L9224, 08L9244) Alinity i Cortisol Reagent Kit (LN 08P3320, 08P3330) ARCHITECT Cortisol Calibrators (LN 8D15-02) ARCHITECT Cortisol Reagent Kit (LN 8D15-25, 8D15-35) ARCHITECT Free T4 Calibrators (LN 7K65-02) ARCHITECT Free T4 Controls (LN 7K65-10) ARCHITECT Free T4 Reagent Kit (LN 7K65-27, 7K65-32, 7K65-35) Alinity i Insulin Reagent Kit (LN 04T7520) ARCHITECT Insulin Reagent Kit (LN 8K41-28) ARCHITECT FSH CALBRATORS (LN 7K75-01) ARCHITECT PROLACTIN CALIBRATORS (LN 7K76-01) ARCHITECT PROGESTERONE CALIBRATORS (LN 7K77-01) CELL-DYN 18 Plus Calibrator ( LN 09H70-01) Emerald 22 Autoloader Analyzer (LN 04R1301) Transplant Pretreatment Tubes (LN 01P0603) ARCHITECT Tacrolimus Whole Blood Precipitation Reagent (LN 01L7755) Alinity i Tacrolimus Reagent Kit (LN 09P4220) ARCHITECT Tacrolimus Reagent Kit (LN 01L7725) ARCHITECT Transplant Pretreatment Tubes (LN 01P0602) ARCHITECT Tacrolimus Calibrators (LN 01L7701) Alinity i Tacrolimus Whole Blood Precipitation Reagent (LN 09P4240) ARCHITECT Prolactin Reagent Kit (LN 7K76-25, 7K76-35) Alinity i Prolactin Reagent Kit (LN 07P6620, 07P6630) Total Bilirubin2 (Alinity c, LN 04U0520) Total Bilirubin2 (ARCHITECT, LN 04T0920 and 04T0930) ARCHITECT 2nd Generation Testosterone Calibrators (LN 2P13-01) ARCHITECT 2nd Generation Testosterone Controls (LN 2P13-10) Alinity i ROMA (LN 03R7521) ARCHITECT ROMA (LN 6P30-21) TOTAL PROTEIN (LN 7D73-21, 7D73-22) Alinity c Total Protein Reagent Kit (LN 07P5220) Total Protein2 (ARCHITECT; LN 04U4420, 04U4430) Total Protein2 (Alinity c; LN 04T8120, 04T8130) ARCHITECT Total T3 Calibrators (LN 7K64-01) ARCHITECT Total T3 Manual Diluent (7K64-50) ARCHITECT Total T3 Reagent Kit (LN 7K64-25, 7K64-35, 7K64-27, 7K64-32, 7K64-37) Alinity i Total T3 Manual Diluent (LN 07P9440) Alinity i Total T3 Reagent Kit (LN 07P9420, 07P9430) ARCHITECT HAVAB-G Reagent Kit (LN 6L27-25) Alinity i HAVAb IgG Reagent Kit (LN 08P2721) ARCHITECT HAVAB-G Controls (LN 6L27-10) ARCHITECT HAVAB-G Calibrator (LN 6L27-01) CELL-DYN 18 Plus Calibrator (LN 07V06-02) CELL-DYN 22 Plus Calibrator (LN 07V11-02) ARCHITECT BNP Controls - LN 8K28-11, 8K28-12, 8K28-13 ARCHITECT BNP Calibrators - LN 8K28-02, 8K28-03, 8K28-04 ARCHITECT BNP Reagent Kit - LN 8K28-27 8K28-35 8K28-28 8K28-36 Alinity c Ecstasy Reagent Kit (LN 09P5820) Ecstasy (LN 03L4220) CELL-DYN 29 Plus Control (w/Retics) (LN 08H58-01, 08H58-02) Alinity h-series Control 29P (LNs 04U7206, 04U7212, 06V87-06, 06V87-12) Alinity i STAT Myoglobin Reagent Kit (LN 04V3720, 04V3730) ARCHITECT STAT Myoglobin Reagent Kit (LN 2K43-20, 2K43-25) ARCHITECT STAT Myoglobin Calibrators (LN 2K43-01) CELL-DYN Retic Plus Control (LN 08H62-01) ALBUMIN BCG (ALBG) (LN 7D53-23, 7D53-24) Alinity c Albumin BCG Reagent Kit (LN 08P0220) Opiates (LN 03L3420) Alinity c Opiates Reagent Kit (LN 09P6520) Alinity c Ethanol Reagent Kit - LN 08P4120 and 08P4130 Ethanol - LN 03L3620 Multichem P Acetaminophen (Alinity c, LN 07P5420) Acetaminophen (LN 03R7420) Ethyl Glucuronide Urine Calibrator 500 Immunalysis Tapentadol Calibrators Carisoprodol Urine Calibrator - 200 ng/mL Immunalysis AB-PINACA Calibrators Alinity c Tobramycin Calibrators (LN 09P9001) Alinity c Cannabinoids Qual Calibrator Kit (LN 09P5401) Alinity c Cannabinoids Semiquant 100 Calibrator Kit (LN 09P5402) Alinity c Ecstasy Qual Calibrator Kit (LN 09P5801) Alinity c Salicylate Calibrator Kit (LN 08P5901) Alinity c Cannabinoids Semiquant 200 Calibrator Kit (LN 09P5403) Alinity c Opiates Semiquant Calibrator Kit (LN 09P6502) Alinity c Ecstasy Semiquant Calibrator Kit (LN 09P5802) Alinity c Opiates Qual Calibrator Kit ( LN 09P6501) Cannabinoid Oral Fluid Calibrator Level 1 Immunalysis Fentanyl Calibrators Cannabinoid Oral Fluid Calibrator Level 2 Ethyl Glucuronide Urine Calibrator - 250 ng/mL Immunalysis Ketamine Calibrators Tapentadol Urine Calibrator 3 - 300ng/mL Ethyl Glucuronide Urine Calibrator - 2000 ng/mL Immunalysis Zolpidem Calibrators Immunalysis Ethyl Glucuronide Urine Calibrators Cannabinoid Oral Fluid Calibrator Level 3 Cannabinoid Oral Fluid Calibrator Level 4 Immunalysis Carisoprodol Calibrators Negative Oral Fluid Calibrator 2 Carisoprodol Urine Calibrator - 50 ng/mL Tapentadol Urine Calibrator 1 - 100ng/mL Immunalysis UR-144 Pentanoic Acid Calibrators Tapentadol Urine Calibrator 4 - 1000ng/mL Ethyl Glucuronide Urine Calibrator 1000 Immunalysis JWH-018 Pentanoic Acid Calibrators Carisoprodol Urine Calibrator - 100 ng/mL Carisoprodol Urine Calibrator - 500 ng/mL Tapentadol Urine Calibrator 2 - 200ng/mL Immunalysis Meperidine Calibrators Ecstasy Oral Fluid Calibrator Level 2 ARCHITECT iCarbamazepine Calibrator A Multi-Pack (LN 1P36-50) ARCHITECT iCarbamazepine Calibrators (LN 1P36-01) ARCHITECT iCarbamazepine Reagent Kit (LN 1P36-27) ACE Control (LN 06U8210) Cystatin C Controls (LN 06T3210) Alinity i Total B-HCG Controls (LN 07P5110) Alinity i Estradiol Controls (LN 07P5010) FreeStyle Control Solution Alinity i Total T4 Controls (LN 07P9510) Alinity i 2nd Generation Testosterone Controls (LN 07P6810) Alinity i Intact PTH Controls (LN 08P3111) Alinity i Prolactin Controls (LN 07P6610) Alinity i Free T4 Controls (LN 7P7010) Alinity i TSH Controls (LN 07P4810) Alinity i Insulin Controls (LN 04T7510) Alinity i FSH Controls (LN 07P4910) Alinity i HE4 Controls (LN 08P5010) Lipase NG OC Control 2 (LN 04Y8511) Alinity i Progesterone Controls (LN 08P3610) Alinity i Syphilis TP Controls (LN 07P6010) Alinity i 25-OH Vitamin D Controls (LN 08P4512) Alinity i CA 125 II Controls (LN 08P4910) Alinity c ASO Control I (LN 04S0912) Alinity c Ammonia Controls (LN 08P2210) Alinity i CA 15-3 Controls (LN 08P5110) ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10) Alinity i CA 19-9XR Controls (LN 08P3210) Lipase NG OC Control 1 (LN 04Y8510) Alinity i Ferritin Controls (LN 07P6510) Alinity c Lp(a) Control Kit (LN 01R1410) Alinity i Homocysteine Controls (LN 09P2810) Alinity i C-Peptide Controls (LN 09P3610) Alinity i Folate Controls (LN 08P1412) Alinity i B12 Controls (LN 07P6712) Alinity i Anti-Tg Controls (LN 09P3410) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610) Alinity c ASO Control II (LN 04S0913) Alinity i DHEA-S Controls (LN 09P3710) Alinity c Hemoglobin A1c Controls (LN 08P4310) Alinity i Anti-TPO Controls (LN 09P3510) Alinity c Cannabinoids Control 2 Kit (LN 09P5411) Alinity c Cannabinoids Control 1 Kit (LN 09P5410) Alinity i T-Uptake Controls (LN 08P1210) ARCHITECT Insulin Controls (LN 08K4112) Alinity i Free T3 Controls (LN 07P6910) MediSense Control Solution Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110) GFAP Controls (Alinity i, LN 04W1710) UCH-L1 Controls (Alinity i, LN 04W1910) GFAP Controls (ARCHITECT, LN 4W16-10) Alinity i BRAHMS PCT Controls (LN 01R1810) Alere NT-proBNP for Alinity i Controls (LN 04S7911) Alinity i CMV IgG Controls (LN 07P4212) ACE Control (LN 06U8610) UCH-L1 Controls (ARCHITECT, LN 4W18-10) Ammonia Controls (LN 6K89-20) Ammonia Ultra (LN 6K89-30) Alinity c Ammonia Ultra Reagent Kit (LN 08P2220) Transplant Pretreatment Tubes - LN 01P0603 ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit - LN 01L7555 ARCHITECT Transplant Pretreatment Tubes - LN 01P0602 ARCHITECT Cyclosporine Reagent Kit - LN 01L7525 ARCHITECT Cyclosporine Calibrators - LN 01L7501 Iron (LN 6K95-30, 6K95-41) Alinity c Methadone Reagent Kit (LN 09P6420) Methadone (LN 03L3520) Alinity i Rubella IgG Reagent Kit (LN 04W02-22) Alinity i Rubella IgG Calibrators (LN 04W02-01) Alinity i Rubella IgG Controls (LN 04W02-10) ARCHITECT FERRITIN Controls (LN 7K59-10) ARCHITECT FERRITIN Reagent Kit (LN 7K59-25, 7K59-35) ARCHTIECT FERRITIN Calibrators (LN 7K59-01) Alinity i Ferritin Reagent Kit (LN 07P6520, 07P6530) Haptoglobin (LN 9D91-21) Alinity c Haptoglobin Reagent Kit (LN 09P5920) Haptoglobin (Alinity c, LN 09P5924) Haptoglobin (ARCHITECT, LN 09D9124) Alinity h-series Water Purification System (LN 09P7101) Alinity hs (09P69-02) ALINITY HS SLIDE MAKER STAINER MODULE (09P69-01) ALINITY HQ ANALYZER (09P68-01) Alinity hq (LN 09P68-02) Ecstasy 750 Calibrator (LN 03L4203) Ecstasy 250 Calibrator (LN 03L4201) Ecstasy 500 Calibrator (LN 03L4202) Ecstasy 1000 Calibrator (LN 03L4204) CRP Calibrator HS (LN 6K26-14) CRP Vario (LN 6K26-30, 6K26-41) CRP Control HS (LN 6K26-21) CRP Calibrator WR (Wide Range) (LN 6K26-12) CRP Calibrator Set (LN 6K26-10) Immunoglobulin A (IgA) (LN 9D98-21, 9D98-22) Specific Proteins Multiconstituent Calibrator (LN 1E78-02) Alinity c Immunoglobulin A Reagent Kit (LN 09P6120) Immunoglobulin A (IgA) (Alinity c, LN 09P6124) Immunoglobulin A (IgA) (ARCHITECT, LN 09D9824) Quantia Ferritin/Myoglobin/IgE Control (LN 6K56-21, 6K56-22) Quantia Immunoglobulin E (LN 6K42-40, 6K42-41) Quantia IgE Calibrators (LN 6K50-02, 6K50-04) Alinity c IgE Calibrators (LN 01R1302) Alinity c Ferritin/Myoglobin/IgE Control Kit (LN 04R4612) Cannabinoids (LN 03L4120) Alinity c Cannabinoids Reagent Kit (LN 09P5420) Total Bilirubin (LN 7P32-21, 7P32-41) ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35) ARCHITECT Total PSA Controls (LN 6C06-10) ARCHITECT Total PSA Calibrators (LN 6C06-01) Alinity i Total PSA Controls (LN 07P9210) Alinity i Total PSA Calibrators (LN 07P9201) Alinity i Total PSA Reagent Kit (LN 07P9221, 07P9231) Quantia ASO Control I (LN 6K54-21, 6K54-22) Alinity c Iron Reagent Kit (LN 08P3920) Iron2 (Alinity c, LN 04T9820) Iron2 (ARCHITECT, LN 04T0230) Iron2 (ARCHITECT, LN 04T0220) Alinity c Ethanol Calibrator Kit (LN 08P4101) Ethyl Alcohol Urine Calibrator 5 mg/dL Immunalysis Ethyl Glucuronide Calibrators CELL-DYN Immuno T-Cell (CD3/4/8) Reagents (LN 07H22-01) Hemoglobin A1c Calibrators - LN 02K9602 Hemoglobin A1c Controls - LN 02K9610 Hemoglobin A1c - LN 02K9620 Alinity c Tobramycin Reagent Kit - LN 09P9020 Tobramycin - LN 07F9320 Alinity h-series Phosphate Buffer (LN 07P8301) Architect Alkaline Phosphatase2 (LN 04S8720, 04S8730) Alinity Alkaline Phosphatase2 (LN 04T8320, 04T8330) Alinity c Serum Benzodiazepines Reagent Kit (LN 09P5320) Serum Benzodiazepines (LN 06L3020) Alinity i HSV-2 IgG Calibrator (LN 04W2102) Alinity i HSV-2 IgG Reagent Kit (LN 04W2127, 04W2137) Alinity i HSV-2 IgG Controls (LN 04W2112) ARCHITECT iGentamicin (LN 1P31-27) ALKALINE PHOSPHATASE (LN 7D55-21, 7D55-22, 7D55-31, 7D55-32) Alinity c Alkaline Phosphatase Reagent Kit (LN 08P2020, 08P2030) Clinical Chemistry Calibrator (LN 6K30-10) Cystatin C (LN 06T3220, 06T3230) CELL-DYN Diluent/Sheath (LN 01H73-01) CELL-DYN Emerald 22 Diluent (LN 09H62-01) CELL-DYN Emerald Diluent (LN 09H48-02) Alinity h-series Diluent (LN 04R2601) ARCHITECT Total T4 Calibrators (LN 7K66-02) Multichem IA Plus ARCHITECT iVancomycin Reagent Kit (LN 1P30-28, 1P30-24) Alinity i Homocysteine Reagent Kit (LN 09P2820) ARCHITECT Homocysteine Reagent Kit (LN 1L71-27) ARCHITECT Homocysteine Calibrators (LN 1L71-01) ARCHITECT Homocysteine Controls (LN 1L71-10) GFAP Reagent Kit (ARCHITECT, LN 4W16-27) UCH-L1 Reagent Kit (ARCHTECT, LN 4W18-27) PHOSPHOURUS (PHOS) (LN 7D71-22, 7D71-31, 7D71-23, 7D71-32) Alinity c Lithium Reagent Kit (LN 08P5320) Lithium (LN 8L25-30) URINE/CSF PROTEIN (UPro) (LN 7D79-21, 7D79-31, 7D79-22, 7D79-32) Alinity c Urine/CSF Protein Reagent Kit (LN 07P5920, 07P5930) ALBUMIN BCP (LN 7D54-21) Alinity c Albumin BCP Reagent Kit (LN 08P0320) Alinity i System Alinity c System Alinity i Refurbished Processing Module (LN 03R65-84) Vancomycin - LN 06E4421 Alinity c Vancomycin Reagent Kit - LN 08P5220 Multichem U ARCHITECT CA19-9XR Reagent Kit - LN 02K9133 Alinity i CA 19-9XR Reagent Kit - LN 08P3221 ARCHITECT CA19-9XR Calibrators - LN 02K9103 ARCHITECT CA19-9XR Controls - LN 02K9112 UIBC Liquid (LN 4P79-30) UIBC (LN 4R29-21) ARCHITECT iGentamicin Calibrators (LN 1P31-01) ARCHITECT iGentamicin Reagent Kit (LN 1P31-25) ARCHITECT iGentamicin (LN 1P31-27) Alinity c Aspartate Aminotransferase Reagent Kit (LN 08P1720) Alinity c Activated Apartate Aminotransferase Reagent Kit (LN 08P2320) Activated Aspartate Aminotransferase (LN 8L91-22, 8L91-42) Aspartate Aminotranserase (LN 7D81-22) Aspartate Aminotransferase2 (ARCHITECT; LN 04S9020, 04S9030) Activated Aspartate Aminotransferase (ARCHITECT, LN 08L9124, 08L9144) Activated Aspartate Aminotransferase (A-AST) (Alinity c, LN 08P2324) Aspartate Aminotransferase2 (Alinity c; LN 04T8620,04T8630) APOLIPOPROTEIN A1 (ApoA) (LN 9D92-21, 9D92-22) Alinity c Apolipoprotein A1 Reagent Kit (LN 09P4620) Apolipoprotein A1 (Alinity c, LN 09P4624) Apolipoprotein A1 (ARCHITECT, LN 09D9224) Phenobarbital - LN 05P0721 Alinity c Phenobarbital Reagent Kit - LN 09P8520 ARCHITECT Free PSA Reagent Kit (LN 6C07-27) ARCHITECT Free PSA Calibrators (LN 6C07-01) ARCHITECT Free PSA Controls (LN 6C07-10) Alinity i Free PSA Controls (LN 07P9310) Alinity i Free PSA Calibrators (LN 07P9301) Alinity i Free PSA Reagent Kit (LN 07P9321, 07P9331) Alinity i STAT CK-MB Calibrators (LN 04V3801) Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (07P5605) Alinity i STAT Myoglobin Calibrators (LN 04V3701) Alinity c CRP Vario Wide Range Calibrator Kit (LN 07P5603) Alinity i HAVAb IgG Calibrator (LN 08P2701) Alinity c CRP Vario High Sensitivity Calibrator Kit (07P5604) Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831) ARCHITECT STAT CK-MB Reagent Kit (LN 2K42-25, 2K42-35) ARCHITECt STAT CK-MB Calibrators (LN 2K42-01) Benzodiazepines - LN 03L3920 Alinity c CRP Vario Reagent Kit (LN 07P5621) ARCHITECT 2nd Generation Testosterone Reagent Kit (LN 2P13-27) Alinity i 2nd Generation Testosterone Reagent Kit (LN 07P6821, 07P6831) SARS-CoV-2-IgG Reagent Kit (ARCHITECT, LN 6R86-20, 6R86-30) AdviseDx SARS-CoV-2 IgM Calibrator Kit (Alinity i, LN 06R9101) SARS-CoV-2 IgG Calibrator Kit (Alinity i, LN 06R9001) SARS-CoV-2 IgG Reagent Kit (Alinity i, LN 06R9020, 06R9030) SARS-CoV-2 IgG Control Kit (Alinity i, LN 06R9010) SARS-CoV-2 IgG Control Kit (ARCHITECT, LN 6R86-10) AdviseDx SARS-CoV-2 IgG II Control Kit (ARCHITECT, LN 6S60-10) AdviseDx SARS-CoV-2 IgG II Control Kit (Alinity i, LN 06S6110) AdviseDx SARS-CoV-2 IgM Control Kit (Alinity i, LN 06R9110) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (Alinity i, LN 06S6101) AdviseDx SARS-CoV-2 IgM Control Kit (ARCHITECT, LN 06R8710) AdviseDx SARS-CoV-2 IgM Reagent Kit (Alinity i, LN 06R9120, 06R9130) SARS-CoV-2 IgG Calibrator Kit (ARCHITECT, LN 6R86-01) AdviseDx SARS-CoV-2 IgM Reagent Kit (ARCHITECT, LN 06R8720, 06R8730) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (ARCHITECT, LN 6S60-01) AdviseDx SARS-CoV-2 IgM Calibrator Kit (ARCHITECT, LN 06R8701) AdviseDx SARS-CoV-2 IgG II (ARCHITECT, LN 6S60-20, 6S60-30) AdviseDx SARS-CoV-2 IgG II (Alinity i, LN 06S6120, 06S6130) Transferrin (LN 1E04-21, 1E04-22, 1E04-42) Alinity c Transferrin Reagent Kit (LN 08P3820) Transferrin (Alinity c, LN 08P3824) Transferrin (ARCHITECT, LN 01E0424 and 01E0444) Multichem S Plus Carbamazepine (LN 05P0521) Alinity c Carbamazepine Reagent Kit (LN 08P5820) Alinity i HE4 Reagent Kit - LN 08P5021 ARCHITECT HE4 Reagent Kit - LN 02P5427 ARCHITECT HE4 Controls - LN 02P5410 ARCHITECT HE4 Calibrators - LN 02P5401 Alinity h-series Glass Slides (LN 09P8420) Alinity i Toxo IgM Controls (LN 07P47-14) Alinity i Toxo IgM Reagent Kit (LN 07P47-40 and 07P47-45) Alinity i Toxo IgM Calibrator (LN 07P47-04) Alinity c Cocaine Reagent Kit (LN 09P5520) ACTIVATED ASPARTATE AMINOTRANSFERASE (LN 8L91-21, 8L91-41) ARCHITECT CORE Controls (LN 6L22-10) ARCHITECT CORE Reagent Kit (LN 6L22-25) ARCHITECT CORE Calibrators (LN 6L22-01) Alinity i Anti-HBc Controls (LN 07P8410) Alinity i Anti-HBc Calibrator (LN 07P8401) Alinity i Anti-HBc Reagent Kit (LN 07P8421, 07P8431) Cannabinoids 125 Control (LN 03L4116) Cannabinoids 40 Control (LN 03L4110) Cannabinoids 60 Control (LN 03L4112) Cannabinoids 75 Control (LN 03L4114) Complement C4 (LN 9D97-21, 9D97-22) Alinity c Complement C4 Reagent Kit (LN 09P5720) Complement C4 (Alinity c, LN 09P5724) Complement C4 (ARCHITECT, LN 09D9724) Alinity c System Alinity ci-series System Control Module (LN 03R7001) Alinity c Processing Module (LN 03R6701) Alinity c System Accessories Alinity c Glucose Reagent Kit (LN 07P5520, 07P5530) Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503) Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201) Alinity c Multiconstituent Calibrator Kit (LN 08P6001) Alinity c ICT Urine Calibrator Kit (LN 08P7001) ICT Urine Calibrator (LN 1E47-03) Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601) Alinity c ICT Serum Calibrator Kit (LN 08P6901) Alinity c Proteins Calibrators (LN 08P6702) ICT Serum Calibrator (LN 1E46-04) Alinity i Anti-CCP Calibrators (LN 09P2701) Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403) Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201) Alinity c Bilirubin Calibrator Kit (LN 08P6101) Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101) Alinity c Iron Calibrator Kit (LN 04U7501) Bilirubin Calibrator (LN 1E66-05) Urine/CSF Protein Calibrator (LN 1E71-03) Carbon Dioxide Calibrator (LN 1E64-03) Specific Proteins Multiconstituent Calibrator (LN 1E78-04) Multiconstituent Calibrator (LN 1E65-06) Lipid Multiconstituent Calibrator (LN 5P56-02) Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501) Consolidated Chemistry Calibrator (Alinity c; LN 04V6201) ARCHITECT TSH Calibrators (LN 7K62-01) ARCHITECT TSH Controls (LN 7K62-10) ARCHITECT TSH Reagent Kit (LN 7K62-25, 7K62-30, 7K62-35) Alinity i TSH Reagent Kit (LN 07P4820, 07P4830) Alinity c Rheumatoid Factor Reagent Kit (LN 04R9921) Rheumatoid Factor Calibrator (LN 8G67-02) Rheumatoid Factor (Alinity c, LN 04R9924) RHEUMATOID FACTOR (RF) (LN 8G66-21) Rheumatoid Factor (ARCHITECT, LN 08G6624) Alinity c Phenytoin Reagent Kit - LN 08P5420 Phenytoin - LN 05P0821 TRIGLYCERIDE (7D74-21, 7D74-22) Alinity c IgE Reagent Kit (LN 01R1321) Alinity c Barbiturates Reagent Kit (LN 09P5120) Barbiturates (LN 03L3820) Hemoglobin A1c (LN 4P52-20, 4P52-22) Hemoglobin A1c Controls (LN 4P52-11) Hemoglobin A1c Calibrators (LN 4P52-01) Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321) TOX Calibrator 3 - LN 06L3603 TOX Negative Calibrator - LN 06L3605 TOX Calibrator 1 - LN 06L3601 TOX Calibrator 2 - LN 06L3602 Architect C-Peptide Controls (LN 3L53-11) Architect C-Peptide Calibrators (LN 3L53-02) LACTATE DEHYDROGENASE (LDH) (LN 2P56-21, 2P56-22, 2P56-42) Alinity c Lactate Dehydrogenase Reagent Kit (LN 07P7420, 07P7430) Lactate Dehydrogenase2 (LN 04T0320, 04T0330, 04T9920, 04T9930) Lipase2 Calibrator (LN 04U0001, 04T0401) LIPASE (LN 7D80-31) Lipase2 (LN 04T0420, 04U0020) Creatinine2 (Alinity c, LN 04T9120) Creatinine2 (ARCHITECT, LN 04S9520) Cholesterol2 (Alinity c, LN 04T8830) Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 ) Alinity i STAT High Sensitivity Troponin-I Reagent Kit (LN 04Z2125, 04Z2135) Alinity c Creatinine (Enzymatic) Reagent Kit (LN 08P0120, 08P0130) Creatinine Enzymatic (LN 8L24-31, 8L24-41) CARBON DIOXIDE (LN 3L80-21, 3L80-31, 3L80-22, 3L80-32, 3L80-42) Alinity c Carbon Dioxide Reagent Kit (LN 07P7220, 07P7230) CELL-DYN 18 Plus Control (LN 09H69-01, 09H69-02) Cannabinoids 50 Calibrator (LN 03L4102) Cannabinoids 20 Calibrator (LN 03L4101) Cannabinoids 200 Calibrator (LN 03L4104) Cannabinoids 100 Calibrator (LN 03L4103) Digoxin - LN 01E0621 Digoxin Calibrators - LN 01E0602 Alinity c Digoxin Reagent Kit - LN 08P3720 Hemoglobin A1c (LN 4P52-20, 4P52-22) Hemoglobin A1c Calibrators (LN 4P52-01) Hemoglobin A1c Controls (LN 4P52-11) Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321) Architect iVancomycin Calibrators (LN 1P30-02) ARCHITECT AFP Calibrators (LN 3P36-01) ARCHITECT AFP Reagent Kit (LN 3P36-25, 3P36-35) ARCHITECT AFP Controls (LN 3P36-10) Alinity i AFP Reagent Kit (LN 07P9020, 07P9030) Alinity i AFP Controls (LN 07P9010) Alinity i AFP Calibrators (LN 07P9001) Alinity i Toxo IgG Calibrators (LN 07P4504) Alinity i Toxo IgG Reagent Kit (LN 07P4540, 07P4545) Alinity i Toxo IgG Controls (LN 07P4514) ARCHITECT Free T3 Calibrators (LN 7K63-02) Alinity c CRP Vario Reagent Kit (LN 07P5624) CRP Vario (LN 6K26-31 and 6K26-42) ARCHITECT Free T4 Reagent Kit (LN 7K65-29, 7K65-34, 7K65-39) Alinity i Free T4 Reagent Kit (LN 07P7020, 07P7030) Alinity c ICT Sample Diluent (LN 07P5320) Salicylate Calibrator - LN 03K0101 Salicylate - LN 03K0120 Alinity c Salicylate Reagent Kit - LN 08P5920 ARCHITECT DHEA-S Calibrators (LN 8K27-02) ARCHITECT DHEA-S Controls (LN 8K27-11) Cystatin C Calibrators (LN 06T3201) Alinity i Syphilis TP Calibrator (LN 07P6001) Alinity i Progesterone Calibrators (LN 08P3601) Alinity i 25-OH Vitamin D Calibrators (LN 08P4501) Alinity i Total T4 Calibrators (LN 07P9501) Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801) Alinity i FSH Calibrators (LN 07P4901) Alinity i Free T4 Calibrators (LN 07P7001) Alinity i B12 Calibrators (LN 07P6702) Alinity c UIBC Calibrator Kit (LN 08P4401) Alinity i Prolactin Calibrators (LN 07P6601) Alinity i Total B-hCG Calibrators (LN 07P5101) Alinity i TSH Calibrators (LN 07P4801) Alinity c Hemoglobin A1c Calibrators (LN 08P4301) Alinity i C-Peptide Calibrators (LN 09P3601) Alinity i Ferritin Calibrators (LN 07P6501) Alinity i Intact PTH Calibrators (LN 08P3102) Alinity i Estradiol Calibrators (LN 07P5001) Lipase NG OC Calibrator (LN 04Y8501) Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601) Alinity i LH Calibrators (LN 07P9101) Alinity i Anti-TPO Calibrators (LN 09P3501) Alinity i T-Uptake Calibrators (LN 08P1201) Alinity i Folate Calibrators (LN 08P1402) Alinity c B2-Microglobulin Calibrator (LN 01R0902) Alinity i Insulin Calibrators (LN 04T7501) Alinity c Prealbumin Calibrator Kit (LN 04S0101) Alinity i CA 15-3 Calibrators (LN 08P5101) Alinity i Anti-Tg Calibrators (LN 09P3401) Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002) Alinity i Cortisol Calibrators (LN 08P3301) Alinity c Lp(a) Calibrators (LN 01R1401) Alinity i CA 125 II Calibrators (LN 08P4901) Alinity i DHEA-S Calibrators (LN 09P3701) Alinity i Homocysteine Calibrators (LN 09P2801) Alinity c ASO Calibrator (LN 01R0602) Alinity i Total T3 Calibrators (LN 07P9401) ARCHITECT Insulin Calibrators (LN 08K4103) Alinity i HE4 Calibrators (LN 08P5001) Alinity i CA 19-9XR Calibrators (LN 08P3201) ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01) ARCHITECT Total T3 Calibrators (LN 7K64-02) Alinity i Free T3 Calibrators (LN 07P6901) Alinity i Tacrolimus Calibrators (LN 09P4201) Prealbumin Calibrator (LN 6E57-03) Alinity i Sirolimus Calibrators (LN 09P4101) Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101) Acetaminophen Calibrator (LN 03R7401) Acetaminophen Calibrator (Alinity c, LN 07P5401) UCH-L1 Calibrators (Alinity i, LN 04W1901) GFAP Calibrators (ARCHITECT, LN 4W16-01) Alinity i BRAHMS PCT Calibrators (LN 01R1801) GFAP Calibrators (Alinity i, LN 04W1701) Alere NT-proBNP for Alinity i Calibrators (LN 04S7902) ACE Calibrator (LN 06U8601) UCH-L1 Calibrators (ARCHITECT, LN 4W18-01) ACE Calibrator (LN 06U8201) Alinity i CMV IgG Calibrators (LN 07P4202) Valproic Acid - LN 01E1320 Alinity c Valproic Acid Reagent Kit - LN 09P9220 ARCHITECT HAVAB-M Controls (LN 6L21-10) ARCHITECT HAVAB-M Reagent Kit (LN 6L21-25) ARCHITECT HAVAB-M Calibrator (LN 6L21-01) Alinity i HAVAb IgM Controls (LN 08P2810) Alinity i HAVAb IgM Reagent Kit (LN 08P2821, 08P2831) Alinity i HAVAb IgM Calibrator (LN 08P2801) Magnesium (LN 3P68-22, 3P68-32) Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930) Magnesium (Alinity c; LN 08P1925, 08P1934) Magnesium (ARCHITECT; LN 03P6824, 03P6834) Alinity i STAT High Sensitivity Troponin-I (LN 04Z2125, 04Z2135) URIC ACID (LN 3P39-21) CELL-DYN HemCal Plus (LN 08H57-01) Alinity h-series HemCal (LN 04U7302, 06V86-02) MAGNESIUM (LN 7D70-21, 7D70-31) Alinity c DOA MC Qual Calibrator 2 Kit (LN 08P6302) Alinity c Tox Qual Calibrators (LN 08P6802) Alinity c DOA MC Negative Calibrator Kit (LN 08P6305, 08P6306) Alinity c DOA MC Qual Low Calibrator 1 Kit (LN 08P6301) Alinity c Benzodiazepines Semiquant Calibrator Kit (LN 09P5202) Alinity c DOA MC Semiquant Calibrator Kit (LN 08P6303) Alinity c Tox Semiquant Calibrators (LN 08P6801) Alinity c TDM Multiconstituent Calibrator Kit (LN 08P7403, 08P7404) Alinity c Benzodiazepines Qual Calibrator Kit (LN 09P5201) Multi-Drug Calibrator Level 4 (15 mL) Negative Reference Calibrator 10 mL Kit Multi-Drug Calibrator Level 3 (15 mL) Multi-Drug Calibrator Level 1 (25mL) Hydrocodone Oral Fluid 4 AMP/6-AM Oral Fluid Calibrator Level 4 Oral Fluid Multi-Analyte Calibrator and Control Set Immunalysis Synthetic Negative Oral Fluid 100 mL Immunalysis Multi-Drug OF Calibrator Level 1 AMP/6-AM Oral Fluid Calibrator Level 1 Hydrocodone Oral Fluid 1 Immunalysis Multi-Drug OF Calibrator Level 4 Hydrocodone Oral Fluid 3 Negative Reference Calibrator Multi-Drug Calibrator Level 2 (15 mL) Multi-Drug Calibrator Level 3 (25 mL) Immunalysis Synthetic Negative Oral Fluid 500 mL Drug Free Negative Urine Calibrator AMP/6-AM Oral Fluid Calibrator Level 2 AMP/6-AM Oral Fluid Calibrator Level 3 Hydrocodone Oral Fluid 2 Immunalysis Multi-Drug OF Calibrator Level 3 Multi-Drug Calibrator Level 2 (25 mL) Immunalysis Multi-Drug OF Calibrator Level 2 Oral Fluid PM Multi-Analyte Calibrator and Control Set Multi-Drug Calibrator Level 4 (25 mL) Multi-Drug Calibrator Level 1 (15mL) Negative Urine Calibrator Tobramycin Calibrators - LN 07F9301 PREALBUMIN (LN 1E02-21, 1E02-22, 01E0224) Prealbumin Calibrator (LN 6E57-02) Alinity c Prealbumin Reagent Kit (LN 09P8620) Prealbumin (Alinity c, LN 09P8624) Alinity c Uric Acid Reagent Kit (LN 08P5620, 08P5630) Uric Acid (LN 3P39-22, 3P39-42) Uric Acid2 (Alinity c; LN 04U0920, 04U0930) Alinity i Active-B12 (Holotranscobalamin) Reagent Kit (LN 09P2620) ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-01) ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-10) ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit (LN 3P24-25) Alinity c Amphetamine/Methamphetamine Reagent Kit (LN 09P4520) Amphetamine/Methamphetamine (LN 03L3720) Lp(a) Controls (LN 5P84-10, 5P84-11) Lp(a) Calibrators (LN 5P83-01, 5P83-02) ARCHITECT CA15-3 Calibrators - LN 02K4402 ARCHITECT CA15-3 Reagent Kit - LN 02K4421 02K4427 02K4437 ARCHITECT CA15-3 Controls - LN 02K4411 Alinity i CA 15-3 Reagent Kit - LN 08P5120 and 08P5130 CELL-DYN EMERALD (LN 09H39-01) Alinity c Amylase Reagent Kit (LN 07P5820) AMYLASE (LN 7D58-21 and 7D58-22) Alinity c Gentamicin Reagent Kit - LN 08P5520 Gentamicin - LN 01E1120 ARCHITECT DHEA-S Reagent Kit (LN 8K27-27) Alinity i DHEA-S Reagent Kit (LN 09P3720) Architect iTheophylline Reagent Kit (LN 1P29-27) Architect iTheophylline Calibrators (LN 1P29-02) CREATINE KINASE (LN 7D63-21, 7D63-22, 7D63-42) Alinity c Creatine Kinase Reagent Kit (LN 08P4220) Alinity c Ultra HDL Reagent Kit (LN 07P7520, 07P7530) ULTRA HDL (LN 3K33-21, 3K33-22) Alinity c Calcium Reagent Kit (LN 07P5720, 07P5730) CALCIUM (LN 3L79-21, 3L79-31, 3L79-22, 3L79-32, 3L79-42) Multichem WBT Alinity c Phencyclidine Reagent Kit - LN 09P6620 Phencyclidine - LN 06L9620 CELL-DYN Ruby System (LN 08H67-01, 08H67-03) Ceruloplasmin (LN 6K91-30) Alinity c Ceruloplasmin Reagent Kit (LN 09P9320) Alinity c B2-Microglobulin Reagent Kit (LN 01R0921) Alinity c A1-Antitrypsin Reagent Kit (LN 01R0721) Quantia PROTEINS Calibrators (LN 6K45-02, 6K45-04) Quantia PROTEINS Control (LN 6K53-21, 6K53-22) Quantia Alpha 1-Antitrypsin (LN 6K99-40, 6K99-41) ARCHITECT SHBG Reagent Kit (LN 8K26-27) Alinity i SHBG Controls (LN 09P3810) Alinity i SHBG Calibrators (LN 09P3801) Alinity i SHBG Reagent Kit (LN 09P3820) ARCHITECT SHBG Controls (LN 8K26-11) ARCHITECT SHBG Calibrators (LN 8K26-02) ARCHITECT Free T3 Reagent Kit (LN 7K63-25, 7K63-35, 7K63-27, 7K63-32, 7K63-37) ARCHITECT Free T3 Calibrators (LN 7K63-01) ARCHITECT Free T3 Controls (LN 7K63-10, 7K63-12) Alinity i Free T3 Reagent Kit (LN 07P6920, 07P6930) ARCHITECT 25-OH Vitamin D Calibrators (LN 5P02-02) ARCHITECT 25-OH Vitamin D Controls (LN 5P02-12) ARCHITECT 25-OH Vitamin D Reagent Kit (LN 5P02-25, 5P02-30, 5P02-35) Alinity i 25-OH Vitamin D Reagent Kit (08P4522, 08P4532) CELL-DYN 22 Plus Control (LN 09H72-01, 09H72-02) Quantia Lipoprotein(a) (LN 7K00-40, 7K00-41) Alinity c Lp(a) Reagent Kit (LN 01R1421) Alinity i T-Uptake Reagent Kit (LN 08P1220) ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825) Amylase2 (04S89-20, 04T8520) Quantia ASO Calibrator (LN 6K46-02, 6K46-04) ARCHITECT Estradiol Reagent Kit (LN 7K72-25, 7K72-35) ARCHITECT Estradiol Manual Diluent (LN 7K72-50) Alinity i Estradiol Reagent Kit (LN 07P5020, 07P5030) Alinity i Estradiol Manual Diluent Kit (LN 07P5040) Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030) Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430) Alinity i Anti-CCP Reagent Kit (LN 09P2720) ARCHITECT Anti-CCP Calibrators (LN 1P65-01) ARCHITECT Anti-CCP Reagent Kit (LN 1P65-25) ARCHITECT Anti-CCP Controls (LN 1P65-10) Alinity c Theophylline Reagent Kit - LN 09P8920 Theophylline - LN 05P0621 ARCHITECT CA125 II Reagent Kit - LN 02K4524 02K4529 and 02K4539 ARCHITECT CA125 II Calibrators - LN 02K4502 ARCHITECT CA125 II Controls - LN 02K4511 Alinity i CA 125 II Reagent Kit - LN 08P4920 and 08P4930 Albumin BCP2 (ARCHITECT, LN 04U4520 and 04U4530) Albumin BCP2 (Alinity c, LN 04T8220 and 04T8230) Alinity c A-1-AGP Reagent Kit (LN 01R0821) Quantia Alpha-1-Acid Glycoprotein (LN 6L34-40, 6L34-41) Opiates 300 Calibrator - LN 03L3402 Opiates 1000 Calibrator - LN 03L3404 Opiates 150 Calibrator - LN 03L3401 Opiates 500 Calibrator - LN 03L3403 Alinity c Proteins Control Kit (LN 08P6712) Alinity i STAT Myoglobin Controls (LN 04V3710) Alinity i Anti-CCP Controls (LN 09P2710) Alinity c CRP Vario HS Control Kit (LN 07P5612) i-STAT TBI Calibration Verification Alinity i STAT CK-MB Controls (LN 04V3810) i-STAT TBI Controls i-STAT hs-TnI Control Level 2 i-STAT hs-TnI Control Level 3 i-STAT hs-TnI Control Level 1 i-STAT hs-TnI Calibration Verification Levels 1-3 TOTAL BILIRUBIN (LN 6L45-21, 6L45-41, 6L45-22, 6L45-42) Alinity c Total Bilirubin Reagent Kit (LN 04V5121, 04V5131) ARCHITECT STAT Troponin-I Calibrators - LN 02K4101 ARCHITECT STAT Troponin-I Reagent Kit - LN 02K4127 and 02K4137 GAMMA-GLUTAMYL TRANSFERASE (GGT) (LN 7D65-21, 7D65-22, 7D65-42) Alinity c Gamma-Glutamyl Transferase Reagent Kit (LN 07P7320, 07P7330) Gamma-Glutamyl Transferase2 (ARCHITECT; LN 04T0020, 04T0030) Gamma-Glutamyl Transferase2 (Alinity c; LN 04T9620, 04T9630) Multichem S Plus Unassayed Multichem U Multichem S Plus Assayed Multichem P Multichem hsTn ARCHITECT STAT Troponin-I Controls - LN 02K4110 Acetaminophen Calibrator - LN 02K9901 ACID PHOSPHATASE (ACP) (LN 9D87-21) Tricyclic Antidepressants (LN 06L2820) Plasmaproteins Calibrator 3X (LN 6K31-10) Alinity i B12 Reagent Kit (LN 07P6721, 07P6731) ARCHITECT B12 Controls (LN 7K61-12) ARCHITECT B12 Calibrators (LN 7K61-02) ARCHITECT B12 Reagent Kit (LN 7K61-27, 7K61-37) DIRECT BILIRUBIN (LN 8G63-21, 8G63-22) Alinity c Direct Bilirubin Reagent Kit (LN 07P9720) DOA MC I Calibrator 3 - LN 03L4303 DOA MC Negative Calibrator - LN 03L4305 DOA MC I Calibrator 2 - LN 03L4302 DOA MC I Calibrator 1 - LN 03L4301 DOA MC I Calibrator 4 - LN 03L4304 ARCHITECT AUSAB Calibrators (LN 1L82-02, 1L82-03) ARCHITECT AUSAB Reagent Kit (LN 1L82-25, 1L82-35, 1L82-26, 1L82-27, 1L82-36, 1L82-37) ARCHITECT AUSAB Controls (LN 1L82-12, 1L82-13) ARCHITECT AUSAB Specimen Diluent (LN 1L82-40) Alinity i Anti-HBs Specimen Diluent (LN 07P8841) Alinity i Anti-HBs Reagent Kit (LN 07P8851, 07P8856) Alinity i Anti-HBs Controls (LN 07P8810) Alinity i Anti-HBs Calibrators (LN 07P8801) ARCHITECT AUSAB Reagent Kit (LN 1L82-28, 1L82-38) Alinity i Anti-HBs Reagent Kit (LN 07P8852, 07P8857) Alinity i CMV IgG Reagent Kit (LN 07P4224, 07P4233) Alinity c Microalbumin Calibrators - LN 08P0401 Microalbumin Calibrators - LN 02K9802 and 02K9803 Alinity c Microalbumin Reagent Kit - LN 08P0420 Microalbumin - LN 02K9820 and 02K9821 Alinity c Microalbumin Controls - LN 08P0410 Microalbumin Controls - LN 02K9810 and 02K9811 Microalbumin Controls (ARCHITECT; LN 02K9814) Microalbumin (Alinity c, LN 08P0424) Microalbumin Controls (Alinity c, LN 08P0414) Microalbumin (ARCHITECT; LN 02K9824) Microalbumin Calibrators (Alinity c, LN 08P0404) Microalbumin Calibrators (ARCHITECT; LN 02K9804) Quantia B2-Microglobulin Calibrator (LN 6K47-02, 6K47-04) Quantia B2-Microglobulin (LN 6K39-40, 6K39-41) Quantia PROTEINS Control (LN 6K53-21, 6K53-22) Alinity h-series Smear Fix (LN 08P7901)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1999-02-12
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-03
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2012-12-03
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-03
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2012-12-03
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2012-12-03
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2019-10-18
LBZ	Enzyme Immunoassay, Quinidine	Clinical Toxicology	Class 2	862.3320	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-12-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-12-07
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2018-12-07
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2018-12-07
PTF	Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	Microbiology	Class 2	866.3215	2018-12-07
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2019-11-29
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2012-05-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-03-08
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-03-08
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2010-03-08
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2007-01-04
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2007-12-07
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-01-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-04-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	1977-12-13
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-09-25
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2007-12-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2023-09-28
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2023-09-28
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-06-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-06-29
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2018-06-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2007-12-07
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2000-12-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-06-29
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2018-06-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-04-11
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2013-04-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-04-11
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2001-02-06
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-18
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2020-01-10
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-03-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
MLM	Enzyme Immunoassay, Tracrolimus	Clinical Chemistry	Class 2	862.1678	2019-09-25
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1996-02-14
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2024-07-15
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2024-07-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-19
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2012-09-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	Class 2	866.6050	2019-09-25
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-04-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	2012-08-13
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2012-08-13
MJY	Kit, Serological, Negative Control	Clinical Chemistry	Class 1	862.1660	2012-08-13
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-08-13
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2025-07-29
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2020-06-25
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2020-01-10
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2019-05-31
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-05-31
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2020-01-10
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2007-12-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2019-09-25
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2019-09-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2023-04-06
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-11-29
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2011-12-16
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2011-12-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-11-22
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2012-12-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-12-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-09-25
MKW	Cyclosporine	Clinical Chemistry	Class 2	862.1235	2019-09-25
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2013-12-18
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-09-25
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2025-11-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-11-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-11-19
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2007-11-05
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1999-01-12
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2023-09-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-02-25
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2025-02-25
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-09-25
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-12-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-12-03
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-12-03
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-07
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2019-09-25
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2016-11-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2016-11-07
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2007-12-05
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2007-12-05
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2007-12-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-05
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-01-17
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2018-09-25
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2019-11-29
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2007-12-05
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2019-09-25
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2019-09-25
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2019-09-25
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2019-09-25
JCC	Ph Buffer	Pathology	Class 1	864.4010	2023-09-27
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2025-12-02
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-09-25
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2025-08-27
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2025-08-27
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2026-01-28
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2011-10-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-02-04
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2025-08-26
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2000-12-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-04-05
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-19
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2012-09-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2024-01-29
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2007-12-07
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Clinical Toxicology	Class 2	862.3560	2012-12-03
JGQ	Turbidimetric, Total Protein	Clinical Chemistry	Class 2	862.1635	2007-12-07
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2007-12-07
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2024-06-05
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2024-06-05
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2024-06-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-06-05
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2024-06-05
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-06-05
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2019-09-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
JQF	Bathophenanthroline, Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2013-12-18
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2011-04-12
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2011-04-12
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2018-05-14
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2007-12-07
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2019-09-25
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2007-12-05
MTG	Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	Unknown	Class 3	N/A	2007-12-05
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-11-29
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-04-08
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2019-04-08
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2019-09-25
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2019-12-21
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2016-07-12
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-16
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-12-07
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
OIU	Test, Epithelial Ovarian Tumor Associated Antigen (He4)	Immunology	Class 2	866.6010	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
KEW	Slides, Microscope	Pathology	Class 1	864.3010	1998-07-09
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2025-03-04
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2019-12-06
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2014-01-16
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2010-05-26
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2010-05-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-02-21
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-07
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-05-03
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-05-03
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-11-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2007-12-07
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2007-12-07
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2019-09-25
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2000-04-24
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2023-08-28
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2020-06-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-07-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-07-09
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2015-07-09
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2015-07-09
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-03
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1999-01-12
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2003-08-04
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2024-07-15
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2025-02-05
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2022-06-07
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-12-03
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2007-12-19
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2020-01-10
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-09-25
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-09-25
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-03-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-03-26
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2014-03-26
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2014-03-26
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2012-12-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-03
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown	Class 3	N/A	2013-01-14
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2022-09-15
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2022-09-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2020-05-19
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2019-09-25
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2018-04-19
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-05-03
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-05-03
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2018-05-03
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-05-03
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-09-25
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2019-09-25
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2007-12-10
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2018-12-18
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2023-05-05
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-05-27
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2020-01-10
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2020-01-10
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2020-01-10
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2020-01-10
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2007-12-07
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-11-29
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2019-09-25
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	1999-01-13
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2018-06-02
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2012-09-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-19
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2019-09-25
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-12-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-16
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-14
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2007-12-19
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2019-09-25
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2012-12-03
LGS	Fluorescence Polarization Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2012-12-03
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-03
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-11-24
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2007-12-10
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2007-12-07
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2022-06-27
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2022-06-27
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2022-06-27
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2022-06-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-06-27
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2014-04-10
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-09-25
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2007-12-05
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2012-12-03
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2019-05-31
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2019-11-29
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2019-09-25
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2012-12-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2007-12-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-10-24
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-10-24
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2016-10-24
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2020-01-10
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-09-25
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2002-05-09
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2025-11-21
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2020-01-17
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1998-07-16
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-07-15
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-09-19
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2012-09-19
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2019-09-25
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-07-16
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2019-09-25
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-09-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-11-13
MQM	Bilirubin (Total And Unbound) In The Neonate Test System	Clinical Chemistry	Class 1	862.1113	2014-01-16
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2014-01-16
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2019-09-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2019-09-25
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2000-12-26
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2014-04-10
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2019-09-25
CKB	Acid Phosphatase, Naphthyl Phosphate	Clinical Chemistry	Class 2	862.1020	2007-12-07
LFH	U.V. Spectrometry, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2024-06-25
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-06-25
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2012-06-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-06-25
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-07
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-12-07
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2019-09-25
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2007-01-04
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2007-01-04
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2023-05-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-09-25
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2019-09-25
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-25
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2023-09-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

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
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17
K833380	E.I. Dupont DE Nemours & Co., Inc.	LIDOAINE CALIBRATOR	1983-12-27
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K851032	Roche Diagnostic Systems, Inc.	COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C	1985-04-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
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-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005333358. Last updated year: 2026. Please use registration number 3005333358 when referencing this establishment in official correspondence.