Trinity Biotech Ultra2 Affinity HbA1c Analyzer (110V)
by Primus Corp.
Trinity Biotech Ultra2 Affinity HbA1c Analyzer (110V) (03-01-0052) is a Class II device made by Primus Corp., cleared under FDA 510(k) K891235 on 16 Jun 1989 and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516748155), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05391516748155 | Date6 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK891235 | Date16 Jun 1989 | StatusActive |
Official records
- AccessGUDID record 05391516748155
- FDA 510(k) database K891235
Across registries
- FDA 510(k) K891235 decided 16 Jun 1989 Active
- FDA GUDID UDI-DI 05391516748155 listed 6 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K891235
- Listed FDA GUDID 05391516748155
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Glycated haemoglobin (HbA1C) analyser IVD
- Model / Ref / Catalog
- Ultra2 Affinity HbA1c Analyzer (110V), 03-01-0052
- Primary DI / UDI-DI
- 05391516748155
- 510(k) Number
- FDA product code
- LCP
- GMDN term
- Glycated haemoglobin (HbA1C) analyser IVD
- Device class
- Class II
- Regulation number
- 864.7470
- GUDID distribution status
- In Commercial Distribution