Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002809144

FEI Number

3002809144

Entity Name

ABBOTT GmbH

City/State/Country

Wiesbaden Hesse, DE

Establishment Address

Max-Planck-Ring 2, Wiesbaden Hesse 65205, DE

Establishment Type(s)

Manufacture Medical Device

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

Alinity c Uric Acid Reagent Kit (LN 08P5620, 08P5630) Uric Acid (LN 3P39-22, 3P39-42) Uric Acid2 (Alinity c; LN 04U0920, 04U0930) ARCHITECT LH Calibrators (LN 2P40-01) Alinity i STAT High Sensitivity Troponin-I Reagent Kit (LN 04Z2125, 04Z2135) ARCHITECT FSH CALBRATORS (LN 7K75-01) ARCHITECT PROLACTIN CALIBRATORS (LN 7K76-01) ARCHITECT PROGESTERONE CALIBRATORS (LN 7K77-01) ARCHITECT Total T4 Calibrators (LN 7K66-02) Cystatin C (LN 06T3220, 06T3230) Alinity i Anti-HBc IgM Reagent Kit (LN 07P8621) Alinity i Anti-HBc IgM Controls (LN 07P8612) Alinity i Anti-HBc IgM Calibrators (LN 07P8602) ARCHITECT CORE-M REAGENT KIT (LN 6L23-25) ARCHITECT CORE-M CALIBRATORS (LN 6L23-01) ARCHITECT CORE-M CONTROLS (LN 6L23-10) 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) Alinity i HAVAb IgG Controls (LN 08P2710) CELL-DYN Emerald Cleaner (LN 09H46-02) CELL-DYN Emerald 22 Easy Cleaner (LN 09H60-03) CELL-DYN Enzymatic Cleaner Concentrate (LN 99644-01) 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 WBC Reagent (LN 07P7904) Lipase2 Calibrator (LN 04U0001, 04T0401) LIPASE (LN 7D80-31) Lipase2 (LN 04T0420, 04U0020) Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131) Alinity i System Accessories Alinity i System Alinity i Refurbished Processing Module (LN 03R65-84) 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 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) 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) Uric Acid2 (ARCHITECT; LN 04T1320, 04T1330) Multichem IA Plus Multichem WBT 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) Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030) Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430) Multichem P 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) Alinity c UIBC Reagent Kit (LN 08P4420) CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02) CELL-DYN CN-Free HGB Reagent (LN 01H79-01) CELL-DYN CN Free HGB/NOC Lyse (LN 03H80-02) CELL-DYN WBC Lyse (LN 08H52-01) CELL-DYN Emerald CN-Free Lyse (LN 09H47-02) CELL-DYN Emerald 22 Lyse (LN 09H6101) Alinity h-series HGB Reagent (LN 07P8104) CELL-DYN WBC Reagent - Part A (LN 01H77-01/01H77-02) Architect Alkaline Phosphatase2 (LN 04S8720, 04S8730) Alinity Alkaline Phosphatase2 (LN 04T8320, 04T8330) 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) 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) 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 Architect iTheophylline Reagent Kit (LN 1P29-27) Architect iTheophylline Calibrators (LN 1P29-02) 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) ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit (LN 3P24-28, 3P24-38) Alinity i Active-B12 (Holotranscobalamin) Reagent Kit (LN 09P2625, 09P2635) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2611) ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-02) ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-11) Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2602) ARCHITECT 2nd Generation Testosterone Calibrators (LN 2P13-01) ARCHITECT 2nd Generation Testosterone Controls (LN 2P13-10) Multichem IA Plus 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) 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) Plasmaproteins Calibrator 3X (LN 6K31-10) Immunoglobulin M (IgM) (LN 1E01-21, 1E01-22) Alinity c Immunoglobulin M Reagent Kit (LN 09P6320) Immunoglobulin M (IgM) (Alinity c, LN 09P6324) Immunoglobulin M (IgM) (ARCHITECT, LN 01E0124) Alinity i STAT High Sensitivity Troponin-I (LN 04Z2125, 04Z2135) Complement C3 (LN 9D96-21, 9D96-22) Alinity c Complement C3 Reagent Kit (LN 09P5620) Complement C3 (ARCHITECT, LN 09D9624) Complement C3 (Alinity c, LN 09P5624) Architect iDigoxin Reagent Kit (LN 1P32-27) Architect iDigoxin Calibrators (LN 1P32-02) UIBC Liquid (LN 4P79-30) UIBC (LN 4R29-21) 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 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 ARCHITECT PROGESTERONE CONTROLS (LN 7K77-10) ARCHITECT FSH CONTROLS (LN 7K75-10) ARCHITECT ESTRADIOL CALIBRATORS (LN 7K72-01) ARCHITECT PROLACTIN CONTROLS (LN 7K76-10) ARCHITECT ESTRADIOL CONTROLS (LN 7K72-10) 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) CELL-DYN EMERALD (LN 09H39-01) 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 s System Accessories Alinity s System ARCHITECT TOTAL B-HCG Controls (LN 7K78-10) ARCHITECT TOTAL B-HCG Calibrators (LN 7K78-01) ARCHITECT TOTAL B-HCG Reagent Kit (LN 7K78-25, 7K78-30, 7K78-35) Emerald 22 Autoloader Analyzer (LN 04R1301) Clinical Chemistry Calibrator (LN 6K30-10) Alinity i CMV IgG Reagent Kit (LN 07P4224, 07P4233) Alinity c Lactic Acid Reagent Kit (LN 08P2120, 08P2121) Lactic Acid (LN 09P1821) Lactic Acid2 (Alinity c, LN 04U2620) Lactic Acid2 (ARCHITECT, LN 04T3020) Alinity h-series Phosphate Buffer (LN 07P8301) ARCHITECT iCarbamazepine Calibrator A Multi-Pack (LN 1P36-50) ARCHITECT iCarbamazepine Calibrators (LN 1P36-01) ARCHITECT iCarbamazepine Reagent Kit (LN 1P36-27) Architect iVancomycin Calibrators (LN 1P30-02) LIPID MULTICONSTITUENT CALIBRATOR (LN 5P56-01) 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) Alinity c Iron Reagent Kit (LN 08P3920) Iron2 (Alinity c, LN 04T9820) Iron2 (ARCHITECT, LN 04T0230) Iron2 (ARCHITECT, LN 04T0220) 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) 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) 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) 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) 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) ARCHITECT System Accessories ARCHITECT System CELL-DYN Emerald 22 (LN 09H5901) Alinity c Phosphorus Reagent Kit (LN 08P4020, 08P4030) Phosphorus2 (Alinity c, LN 04U0320, 04U0330) Phosphorus2 (ARCHITECT, LN 04T0720, 04T0730) Multichem U 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 Lithium Reagent Kit (LN 08P5320) Lithium (LN 8L25-30) ARCHITECT iGentamicin (LN 1P31-27) ARCHITECT HBsAg Next Confirmatory Reagent Kit (LN 4P77-27) ARCHITECT HBsAg Next Qualitative Reagent Kit (LN 4P76-27, 4P76-37, 4P76-32) ARCHITECT HBsAg Next Qualitative Calibrators (LN 4P76-02) Alinity i HBsAg Next Qualitative Calibrators (LN 01R6402) Alinity i HBsAg Next Qualitative Controls (LN 01R6412) Alinity i HBsAg Next Confirmatory Manual Diluent (LN 01R6542) ARCHITECT HBsAg Next Qualitative Controls (LN 4P76-12) ARCHITECT HBsAg Next Confirmatory Manual Diluent (LN 4P77-42) Alinity i HBsAg Next Confirmatory Reagent Kit (LN 01R6521) Alinity i HBsAg Next Qualitative Reagent Kit (LN 01R6421, 01R6431) 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) 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) 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) Cholesterol2 (Alinity c, LN 04T8830) Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 ) 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) Alinity c Ceruloplasmin Reagent Kit (LN 09P9320) ARCHITECT DHEA-S Reagent Kit (LN 8K27-27) Alinity i DHEA-S Reagent Kit (LN 09P3720) Ceruloplasmin (LN 6K91-30) Multichem S Plus Unassayed Multichem U Multichem S Plus Assayed Multichem P Multichem hsTn ARCHITECT LH Reagent Kit (LN 2P40-25, 2P40-35) Alinity i LH Reagent Kit (LN 07P9120, 07P9130) Walgreens Ovulation Predictor Test CVS Ovulation Predictor Test Rite Aid Ovulation Predictor Test Multichem S Plus Architect C-Peptide Controls (LN 3L53-11) Architect C-Peptide Calibrators (LN 3L53-02) ARCHITECT HIV Ag/Ab Combo Calibrator (LN 2P36-01) ARCHITECT HIV Ag/Ab Combo Reagent Kit (LN 2P36-25, 2P36-35) ARCHITECT HIV Ag/Ab Combo Controls (LN 2P36-10) Alinity i HIV Ag/Ab Combo Calibrator (LN 08P0702) Alinity i HIV Ag/Ab Combo Reagent Kit (LN 08P0721, 08P0731) Alinity i HIV Ag/Ab Combo Controls (LN 08P0712) Haptoglobin (LN 9D91-21) Alinity c Haptoglobin Reagent Kit (LN 09P5920) Haptoglobin (Alinity c, LN 09P5924) Haptoglobin (ARCHITECT, LN 09D9124) ARCHITECT Free T4 Reagent Kit (LN 7K65-29, 7K65-34, 7K65-39) Alinity i Free T4 Reagent Kit (LN 07P7020, 07P7030) 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) 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) ARCHITECT CEA Reagent Kit (LN 7K68-27, 7K68-32, 7K68-35) ARCHITECT CEA Controls (LN 7K68-12) ARCHITECT CEA Calibrators (LN 7K68-02) Alinity i CEA Calibrators (LN 07P6201) Alinity i CEA Reagent Kit (LN 07P6220, 07P6230) Alinity i CEA Controls (LN 07P6210) Ammonia Controls (LN 6K89-20) Ammonia Ultra (LN 6K89-30) Alinity c Ammonia Ultra Reagent Kit (LN 08P2220) 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) Alinity i Insulin Reagent Kit (LN 04T7520) ARCHITECT Insulin Reagent Kit (LN 8K41-28) 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) Alinity h-series Smear Fix (LN 08P7901) ARCHITECT Phenobarbital Reagent Kit (LN 1P33-25) ARCHITECT Phenobarbital Calibrators (LN 1P33-01) 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) Alinity i ROMA (LN 03R7521) ARCHITECT ROMA (LN 6P30-21) ARCHITECT iGentamicin Calibrators (LN 1P31-01) ARCHITECT iGentamicin Reagent Kit (LN 1P31-25) ARCHITECT iGentamicin (LN 1P31-27) 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) ARCHITECT iPhenytoin Calibrators (LN 1P34-01) ARCHITECT iPhenytoin Reagent Kit (LN 1P34-25) Alinity i Toxo IgG Calibrators (LN 07P4504) Alinity i Toxo IgG Reagent Kit (LN 07P4540, 07P4545) Alinity i Toxo IgG Controls (LN 07P4514) GFAP Reagent Kit (ARCHITECT, LN 4W16-27) UCH-L1 Reagent Kit (ARCHTECT, LN 4W18-27) HAVAb IgG II Calibrator (LN 06S9301) HAVAb IgG II Reagent Kit (LN 06S9321) HAVAb IgG II Controls (LN 06S9310) Alinity i T-Uptake Reagent Kit (LN 08P1220) ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825) Multichem A1c Total Bilirubin2 (Alinity c, LN 04U0520) Total Bilirubin2 (ARCHITECT, LN 04T0920 and 04T0930) Alinity h-series May-Grunwald-Giemsa Stain (LN 08P8101) Alinity h-series Wright-Giemsa Stain (LN 08P8001) 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) ACE Reagent (LN 06U8625) ACE Reagent (LN 06U8225) Amylase2 (04S89-20, 04T8520) ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit (LN 2R98-25, 2R98-35) 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 h-series Glass Slides (LN 09P8420) 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) 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) ARCHITECT DHEA-S Calibrators (LN 8K27-02) ARCHITECT DHEA-S Controls (LN 8K27-11) Alinity c Creatinine (Enzymatic) Reagent Kit (LN 08P0120, 08P0130) Creatinine Enzymatic (LN 8L24-31, 8L24-41) ARCHITECT Galectin-3 Reagent Kit - LN 05P0327 ARCHITECT Galectin-3 Calibrators - LN 05P0301 ARCHITECT Galectin-3 Controls - LN 05P0310 Alinity i Anti-Tg Reagent Kit (LN 09P3420) ARCHITECT Anti-Tg Controls (LN 2K46-10) ARCHITECT Anti-Tg Reagent Kit (LN 2K46-20, 2K46-25) ARCHITECT Anti-Tg Calibrators (LN 2K46-01) 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) GFAP Reagent Kit (Alinity i, LN 04W1722) UCH-L1 Reagent Kit (Alinity i, LN 04W1922) ARCHITECT Prolactin Reagent Kit (LN 7K76-25, 7K76-35) Alinity i Prolactin Reagent Kit (LN 07P6620, 07P6630) Various XPS Alinity i HAVAb IgG Controls (LN 08P2710)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2018-06-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-06-29
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2022-06-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-04-05
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2025-08-26
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2007-12-07
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2007-12-07
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-11-30
MJX	Kit, Serological, Positive Control	Clinical Chemistry	Class 1	862.1660	2020-10-14
JCB	Detergent	Pathology	Class 1	864.4010	2000-12-26
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
GGJ	Fluid, Diluting, White-Cell	Hematology	Class 1	864.8200	2023-09-27
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2003-08-04
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-05-03
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2018-05-03
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
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
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
CDO	Acid, Uric, Uricase (U.V.)	Clinical Chemistry	Class 1	862.1775	2022-04-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-07-24
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2014-04-10
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2019-11-29
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	2014-04-10
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
JQF	Bathophenanthroline, Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2018-09-25
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1994-09-21
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2025-12-02
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
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2007-12-07
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
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
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
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2025-09-10
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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
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
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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-12-03
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2007-12-19
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2023-05-05
CZW	Complement C3, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-07
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
JQF	Bathophenanthroline, Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2013-12-18
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
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
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-18
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-14
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2018-12-18
MZA	Test, Equipment, Automated Bloodborne Pathogen	Unknown	Class N	N/A	2016-12-15
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2007-12-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-03-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-02-04
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2023-05-18
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	1999-12-03
JCC	Ph Buffer	Pathology	Class 1	864.4010	2023-09-27
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
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
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
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-01-16
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2012-05-16
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2018-09-25
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2018-05-14
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
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2007-12-10
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
MZO	Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	Microbiology	Class 2	866.3169	2007-01-04
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	1977-12-13
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2015-10-13
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2018-06-02
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2007-12-07
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Clinical Toxicology	Class 2	862.3560	2012-12-03
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2026-01-28
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-02-08
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2025-03-04
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
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
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2025-02-05
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
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2019-05-31
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2012-12-03
JFR	Indirect Copper Assay, Ceruloplasmin	Immunology	Class 2	866.5210	2012-12-03
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2014-04-10
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1999-02-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-04-10
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
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2010-07-08
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1999-01-12
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2018-04-19
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
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Immunology	Class 2	866.5580	2007-12-07
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2007-12-07
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
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
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2001-02-06
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
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2023-09-28
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-12-03
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2012-12-03
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1999-02-12
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	Class 2	866.6050	2019-09-25
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
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2000-12-26
LGR	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	Clinical Toxicology	Class 2	862.3350	2012-12-03
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2012-12-03
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
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2024-01-29
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2023-09-18
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2023-09-18
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2023-09-18
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2002-05-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-04-25
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
GJL	Romanowsky Stains	Hematology	Class 1	864.1850	2023-09-28
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
KQN	Radioassay, Angiotensin Converting Enzyme	Clinical Chemistry	Class 2	862.1090	2025-02-07
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2025-11-21
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2019-10-18
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
KEW	Slides, Microscope	Pathology	Class 1	864.3010	1998-07-09
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-04-19
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1999-01-12
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
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-12-03
OSX	Galectin-3 In Vitro Diagnostic Assay	Clinical Chemistry	Class 2	862.1117	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
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
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-06-29
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2007-12-07
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2023-05-30
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	1996-02-14
EQJ	Bur, Ear, Nose And Throat	Ear, Nose, Throat	Class 1	874.4140	2008-01-16
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-01-16
MJY	Kit, Serological, Negative Control	Clinical Chemistry	Class 1	862.1660	2020-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

Sara Qadri Business: ABBOTT LABORATORIES Email: sara.qadri@abbott.com Phone: (224) 6680142

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

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
K830679	Dow Instruments & Reagents, Inc.	URIC ACID COLORIMETRIC DETERMINATION	1983-04-06
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
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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Registration Number	Establishment Name	Location
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
2085064	CLINIQA CORPORATION	San Marcos, CA, US
3038206980	CHANGCHUN MERYDI BIO-TECH CO., LTD.	changchun Jilin, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002809144. Last updated year: 2026. Please use registration number 3002809144 when referencing this establishment in official correspondence.