FDA Registration
Active
🇺🇸 United States
ABBOTT LABORATORIES
Reg #: 1415939
·
FEI: 1415939
·
Expires 2026
Products
16
Proprietary Names
210
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- ABBOTT LABORATORIES
- Registration Number
- 1415939
- FEI Number
- 1415939
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 ABBOTT PARK RD.
- City
- Abbott Park
- State
- IL
- ZIP
- 60064
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081495
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cyclosporine | MKW | Class 2 | Clinical Chemistry | No | 2019-12-15 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2013-01-14 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 1977-12-13 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2016-12-15 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2012-09-19 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2012-09-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-09-19 |
| Ovarian Adnexal Mass Assessment Score Test System | ONX | Class 2 | Obstetrics/Gynecology | No | 2019-09-25 |
| Sirolimus Test System | NRP | Class 2 | Clinical Toxicology | No | 2019-09-25 |
| Enzyme Immunoassay, Tracrolimus | MLM | Class 2 | Clinical Chemistry | No | 2019-09-25 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2019-01-30 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2018-05-03 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-04-16 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2019-09-25 |
| Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations | QHM | Class U | Microbiology | No | 2025-05-21 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2018-05-03 |
Proprietary Names
Alinity i Cyclosporine Whole Blood Precipitation Reagent Kit
CELL-DYN EMERALD (LN 09H39-01)
ARCHITECT System Accessories
ARCHITECT System
Alinity s System Accessories
Alinity s System
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)
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)
CELL-DYN Emerald 22 (LN 09H5901)
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)
ARCHITECT Transplant Pretreatment Tubes (LN 1P06-02)
Transplant Pretreatment Tubes (LN 1P06-03)
ARCHITECT Sirolimus Reagent Kit (LN 1L76-25)
ARCHITECT Sirolimus Calibrators (LN 1L76-01)
ARCHITECT Sirolimus Whole Blood Precipitation Reagent (LN 1L76-55)
Alinity i Sirolimus Whole Blood Precipitation Reagent (LN 09P4140)
Alinity i Sirolimus Reagent Kit (LN 09P4120)
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)
Alinity n Sample Tip (LN 0TN43-01)
Alinity n Amplification Vessel (LN 0TN41-01)
Alinity n Wash Vessel (LN 0TN42-01)
Alinity m Transport Tube
Alinity m Transport Tube Pierceable Capped
Alinity m LRV Tube
Alinity m Pierceable Cap
Alinity m Aliquot Tube
Alinity m Bottle for Ethanol Use
Alinity n Eluate Tip (LN 0TN44-01)
Alinity n Lysis Tube and Tip (LN 0TN40-01)
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)
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)
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
ARCHITECT 2nd Generation Testosterone Reagent Kit (LN 2P13-27)
Alinity i 2nd Generation Testosterone Reagent Kit (LN 07P6821, 07P6831)
Alinity s Syphilis Calibrator Kit (LN 06P09-05)
Alinity s HTLV I/II Calibrator Kit (LN 06P07-05)
Alinity s HBsAg Assay Control Kit (LN 06P02-16)
Alinity s HIV Ag/Ab Combo Assay Control Kit (LN 06P01-13)
Alinity s HBsAg Calibrator Kit (LN 06P02-05)
Alinity s Syphilis Reagent Kit (LN06P0956)
Alinity s Anti-HBc Reagent Kit (LN06P0656)
Alinity s Chagas Reagent Kit (LN06P0856)
Alinity s HTLV I/II Reagent Kit (LN06P0756)
Alinity s Chagas Calibrator Kit (LN 06P08-05)
Alinity s HBsAg Reagent Kit (LN06P0256)
Alinity s HIV Ag/Ab Combo Release Control Kit (LN 06P01-21)
Alinity s Chagas Release Control Kit (LN 06P08-21)
Alinity s Anti-HBc Calibrator Kit (LN 06P06-05)
Alinity s Anti-HCV II Release Control Kit (LN 04W56-21)
Alinity s HBsAg Release Control Kit (LN 06P02-21)
Alinity s HTLV I/II Release Control Kit (LN 06P07-21)
Alinity s HTLV I/II Assay Control Kit (LN 06P07-13)
Alinity s Syphilis Assay Control Kit (LN 06P09-13)
Alinity s HIV Ag/Ab Combo Calibrator Kit (LN 06P01-04)
Alinity s Chagas Assay Control Kit (LN 06P08-13)
Alinity s Anti-HCV II Calibrator Kit (LN 04W56-05)
Alinity s Anti-HBc Assay Control Kit (LN 06P06-13)
Alinity s Anti-HCV II Assay Control Kit (LN 04W56-13)
Alinity s HIV Ag/Ab Combo Reagent Kit (LN06P0156)
Alinity s Anti-HCV II Reagent Kit (LN04W5658)
Alinity s Anti-HBc Release Control Kit (LN 6P06-21)
Alinity s Syphilis Release Control Kit (LN 06P09-21)
Alinity s HBsAg Confirmatory Reagent Kit (LN06P0356)
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)
Establishment Types
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device