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Sign in to claim this brandAbbott Ireland Diagnostics Division
US
Last updated May 23, 2026
What Abbott Ireland Diagnostics Division makes
Abbott Ireland Diagnostics Division manufactures in vitro diagnostic reagents for clinical chemistry testing, including assays for amylase, creatinine, alkaline phosphatase, urea nitrogen, total bilirubin, albumin (BCP and BCG methods), and cholesterol.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Abbott Ireland Diagnostics Division manufacture?
Abbott Ireland Diagnostics Division manufactures in vitro diagnostic reagents for clinical chemistry testing, including assays for amylase, creatinine, alkaline phosphatase, urea nitrogen, total bilirubin, albumin (BCP and BCG methods), and cholesterol, as these are the specific devices listed in the provided data.
Where is Abbott Ireland Diagnostics Division based?
Abbott Ireland Diagnostics Division is based in the United States, as explicitly stated in the COMPANY and COUNTRY fields of the device data.
Which regulatory registries list the devices made by Abbott Ireland Diagnostics Division?
The devices manufactured by Abbott Ireland Diagnostics Division are listed in the FDA 510(k) registry, as indicated in the LISTED IN field of the provided data.
How are the devices made by Abbott Ireland Diagnostics Division classified?
The devices are classified as Class I and Class II medical devices, as stated in the DEVICE CLASSES field, meaning they are subject to general controls and, for Class II, special controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (199)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alinity | 01R3565 | FDA UDI | N | Active |
| Alinity | 08P1220 | FDA UDI | Class II | Active |
| Alinity | 06R9130 | FDA UDI | N | Active |
| Architect | 2K46-10 | FDA UDI | Class II | Active |
| Alinity | 07P8841 | FDA UDI | Class II | Active |
| Architect | 04W1610 | FDA UDI | Class I | Active |
| Architect | 4P76-02 | FDA UDI | Class II | Active |
| Alinity | 07P9221 | FDA UDI | Class III | Active |
| Alinity | 08P1141 | FDA UDI | Class II | Active |
| Alinity | 04W1910 | FDA UDI | Class I | Active |
| Architect | 3P36-35 | FDA UDI | Class III | Active |
| Architect | 1L82-12 | FDA UDI | Class II | Active |
| Architect | 04W1627 | FDA UDI | Class II | Active |
| Alinity | 04W2027 | FDA UDI | Class II | Active |
| Architect | 1L76-01 | FDA UDI | Class II | Active |
| Architect | 06R8710 | FDA UDI | N | Active |
| Architect | 1L82-25 | FDA UDI | Class II | Active |
| Architect | 1L82-13 | FDA UDI | Class II | Active |
| Architect | 2K43-10 | FDA UDI | Class I | Active |
| Alinity | 04W1710 | FDA UDI | Class I | Active |
| Architect | 06S6020 | FDA UDI | N | Active |
| Architect | 07K68-02 | FDA UDI | Class II | Active |
| Architect | 2K42-01 | FDA UDI | Class II | Active |
| Architect | 1L77-55 | FDA UDI | Class II | Active |
| Alinity | 07P9201 | FDA UDI | Class III | Active |
| Architect | 06S6001 | FDA UDI | N | Active |
| Architect | 1L77-25 | FDA UDI | Class II | Active |
| Architect | 4P54-25 | FDA UDI | Class II | Active |
| Architect | 1L82-37 | FDA UDI | Class II | Active |
| Architect | 6C06-27 | FDA UDI | Class II | Active |
| Alinity | 06P1270 | FDA UDI | N | Active |
| Alinity | 09P4101 | FDA UDI | Class II | Active |
| Alinity | 04V3730 | FDA UDI | Class II | Active |
| Architect | 04W1827 | FDA UDI | Class II | Active |
| Alinity | 08P1021 | FDA UDI | Class II | Active |
| Architect | 1L82-36 | FDA UDI | Class II | Active |
| Alinity | 07P6230 | FDA UDI | Class II | Active |
| Architect | 07K68-27 | FDA UDI | Class II | Active |
| Alinity | 04W1922 | FDA UDI | Class II | Active |
| Alinity | 08P1031 | FDA UDI | Class II | Active |
| Architect | 6C07-10 | FDA UDI | Class III | Active |
| Amylase2 | K210633 | FDA 510(k) | Class II | Active |
| Creatinine2 | K210452 | FDA 510(k) | Class II | Active |
| Alkaline Phosphatase2 | K223317 | FDA 510(k) | Class II | Active |
| Urea Nitrogen2 | K203771 | FDA 510(k) | Class II | Active |
| Total Bilirubin2 | K223324 | FDA 510(k) | Class II | Active |
| Albumin BCP2 | K203530 | FDA 510(k) | Class II | Active |
| Cholesterol2 | K203597 | FDA 510(k) | Class I | Active |
| Albumin BCG2 | K203248 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Abbott Ireland Diagnostics Division Longford · IE FEI 3005094123