FDA Registration
Active
🇮🇪 Ireland
ABBOTT IRELAND
Reg #: 3008344661
·
FEI: 3008344661
·
Expires 2026
Products
33
Proprietary Names
251
Establishment Types
3
Classifications
33
Registration Details
- Registration Name
- ABBOTT IRELAND
- Registration Number
- 3008344661
- FEI Number
- 3008344661
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DIAGNOSTICS DIVISION, FINISKLIN BUSINESS PARK
- City
- SLIGO
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K052407
- PMA Number
- P980007
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
US Agent
- Business Name
- ABBOTT LABORATORIES
- Contact Name
- Sara Qadri
- Address
- 675 N Field Dr, Dept C2D8 Bldg CP01 Floor-3
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 6680142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2002-05-09 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2023-09-27 |
| Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | MTF | Class 3 | Unknown | No | 2007-12-05 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2007-12-05 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2018-06-29 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-06-29 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2018-06-29 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-05-03 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2018-05-03 |
| Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | LOK | Class 3 | Unknown | No | 2013-01-14 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2007-12-05 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2007-12-05 |
| Fluorometric, Cortisol | JFT | Class 2 | Clinical Chemistry | No | 2018-06-29 |
| Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | Class 2 | Microbiology | No | 2023-02-08 |
| Brain Trauma Assessment Test | QAT | Class 2 | Immunology | No | 2024-01-29 |
| Fluid, Diluting, White-Cell | GGJ | Class 1 | Hematology | No | 2023-09-27 |
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2020-04-16 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2025-08-27 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | MYF | Class 2 | Microbiology | No | 2025-08-27 |
| Sirolimus Test System | NRP | Class 2 | Clinical Toxicology | No | 2019-09-25 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2019-05-31 |
| Stain, Reticulocyte | GJH | Class 1 | Hematology | No | 2011-01-12 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2023-05-18 |
| Enzyme Immunoassay, Tracrolimus | MLM | Class 2 | Clinical Chemistry | No | 2019-09-25 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 1994-09-21 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2025-11-19 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2016-12-15 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2007-12-07 |
| Procalcitonin Assay | PRI | Class 2 | Microbiology | No | 2018-12-07 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2018-12-07 |
| Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | PTF | Class 2 | Microbiology | No | 2018-12-07 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2019-04-08 |
| Qualitative And Quantitative Hepatitis B Virus Antibody Assays | SEI | Class 2 | Microbiology | No | 2007-01-04 |
Proprietary Names
Alinity i T-Uptake Reagent Kit (LN 08P1220)
ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825)
Alinity h-series Phosphate Buffer (LN 07P8301)
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 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 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 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)
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)
Alinity i Cortisol Reagent Kit (LN 08P3320, 08P3330)
ARCHITECT Cortisol Calibrators (LN 8D15-02)
ARCHITECT Cortisol Reagent Kit (LN 8D15-25, 8D15-35)
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)
GFAP Reagent Kit (ARCHITECT, LN 4W16-27)
UCH-L1 Reagent Kit (ARCHTECT, LN 4W18-27)
Alinity h-series WBC Reagent (LN 07P7904)
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)
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)
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 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)
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 Sapphire System Reticulocyte Reagent (LN 01H76-01)
Alinity h-series Retic Reagent (LN 07P8004)
CELL-DYN Reticulocyte Reagent (LN 03H40-01)
Alinity i CMV IgG Reagent Kit (LN 07P4224, 07P4233)
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)
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 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)
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 s System Accessories
Alinity s System
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)
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)
ARCHITECT System Accessories
ARCHITECT System
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 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)
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)
GFAP Reagent Kit (Alinity i, LN 04W1722)
UCH-L1 Reagent Kit (Alinity i, LN 04W1922)
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)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility