Is this your brand? Sign in to claim ownership.
Sign in to claim this brandABBOTT IRELAND
US
Last updated May 24, 2026
What ABBOTT IRELAND makes
The company manufactures in vitro diagnostic (IVD) kits and systems for measuring thyroid hormones—including free thyroxine (FT4), total thyroxine (TT4), total triiodothyronine (TT3), free triiodothyronine (FT3), and thyroid stimulating hormone (TSH)—using chemiluminescent immunoassay technology. It also produces kits for albumin, progesterone, and total aspartate aminotransferase (AST) assays, primarily using spectrophotometry. These products are designed for laboratory use in automated platforms like ARCHITECT and Alinity.
The diagnostic kits fall under FDA device classes I and II, with regulatory submissions including 510(k) clearances and Unique Device Identifier (UDI) listings. The company’s products are authorised for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Abbott Ireland manufacture?
Abbott Ireland manufactures in vitro diagnostic (IVD) kits and automated systems for laboratory testing. These include chemiluminescent immunoassay kits for thyroid hormones—such as free thyroxine (FT4), total thyroxine (TT4), total triiodothyronine (TT3), free triiodothyronine (FT3), and thyroid stimulating hormone (TSH)—as well as spectrophotometry-based kits for albumin, progesterone, and total aspartate aminotransferase (AST). The devices are designed for use in automated platforms like ARCHITECT and Alinity.
Where is Abbott Ireland based, and what is its primary market focus?
Abbott Ireland is based in the United States. Its primary focus is on developing and manufacturing in vitro diagnostic (IVD) devices authorised for use in the U.S. market. The company specialises in thyroid hormone assays and other laboratory tests, catering to clinical and diagnostic needs in healthcare settings.
Which regulatory registries list Abbott Ireland’s devices?
Abbott Ireland’s devices are listed in the FDA’s 510(k) clearance registry and the Unique Device Identifier (UDI) database. These registries document regulatory submissions and authorisations required for IVD devices in the United States, ensuring compliance with FDA requirements.
How are Abbott Ireland’s devices classified under FDA regulations?
Abbott Ireland’s IVD devices fall under FDA device classes I and II. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification is determined based on the device’s intended use and potential health impact.
What technologies are used in Abbott Ireland’s diagnostic kits?
Abbott Ireland’s diagnostic kits primarily utilise chemiluminescent immunoassay technology for thyroid hormone assays (e.g., FT4, TT4, FT3, TT3, TSH) and spectrophotometry for tests like albumin, progesterone, and AST. These technologies enable precise and automated measurements in clinical laboratory settings, improving diagnostic accuracy and efficiency.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(877)422-2688
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 989964119
Catalogue (240)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Architect | 7K62-30 | FDA UDI | Class II | Active |
| Alinity | 04T9620 | FDA UDI | Class I | Active |
| Alinity | 07P6510 | FDA UDI | Class I | Active |
| Alinity | 08P1460 | FDA UDI | Class II | Active |
| Alinity | 07P6610 | FDA UDI | Class I | Active |
| Architect | 7K72-50 | FDA UDI | Class I | Active |
| Architect | 07K6337 | FDA UDI | Class II | Active |
| Architect | 04T0720 | FDA UDI | Class I | Active |
| Alinity | 04U0330 | FDA UDI | Class I | Active |
| Alinity | 07P5110 | FDA UDI | Class I | Active |
| Alinity | 07P9520 | FDA UDI | Class II | Active |
| Alinity | 07P6620 | FDA UDI | Class I | Active |
| Architect | 04T0930 | FDA UDI | Class II | Active |
| Alinity | 07P5040 | FDA UDI | Class I | Active |
| Architect | 7K65-29 | FDA UDI | Class II | Active |
| Architect | 09D9324 | FDA UDI | Class II | Active |
| Architect | 7K65-32 | FDA UDI | Class I | Active |
| Architect | 7K78-01 | FDA UDI | Class II | Active |
| Alinity | 07P6731 | FDA UDI | Class II | Active |
| Alinity | 07P5001 | FDA UDI | Class II | Active |
| Architect | 7K61-02 | FDA UDI | Class II | Active |
| Architect | 07K6432 | FDA UDI | Class II | Active |
| Alinity | 07P6520 | FDA UDI | Class II | Active |
| Alinity | 08P1421 | FDA UDI | Class II | Active |
| Alinity | 04T8120 | FDA UDI | Class II | Active |
| Alinity | 07P5121 | FDA UDI | Class II | Active |
| Alinity | 08P3824 | FDA UDI | Class II | Active |
| Architect | 7K78-25 | FDA UDI | Class II | Active |
| Alinity | 07P7010 | FDA UDI | Class I | Active |
| Architect | 02R9801 | FDA UDI | Class II | Active |
| Architect | 07K6302 | FDA UDI | Class II | Active |
| Architect | 04T1320 | FDA UDI | Class I | Active |
| Architect | 04S9230 | FDA UDI | Class I | Active |
| Architect | 7K77-50 | FDA UDI | Class I | Active |
| Architect | 5P02-25 | FDA UDI | Class II | Active |
| Alinity | 07P7001 | FDA UDI | Class II | Active |
| Alinity | 08P2324 | FDA UDI | Class II | Active |
| Alinity | 04V6201 | FDA UDI | Class II | Active |
| Glucose2 | K252357 | FDA 510(k) | Class II | Active |
| Calcium2 | K244042 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Abbott Ireland SLIGO · IE FEI 3008344661