Trinity Biotech
Trinity Biotech (01-04-0045) is a Class II device made by Primus Corp., listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516748322), registry data as of 21 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05391516748322 | Date6 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05391516748322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Multiple haemoglobin subtype IVD, control
- Model / Ref / Catalog
- Premier Resolution A2+F Control Material Kit, 01-04-0045
- Primary DI / UDI-DI
- 05391516748322
- FDA product code
- JCM
- GMDN term
- Multiple haemoglobin subtype IVD, control
- Device class
- Class II
- Regulation number
- 864.7415
- GUDID distribution status
- In Commercial Distribution
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