Trinity Biotech 2325300
Trinity Biotech 2325300 is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K873088 on 9 Sep 1987 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 05391516743433), 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 | Number05391516743433 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK873088 | Date9 Sep 1987 | StatusActive |
Official records
- AccessGUDID record 05391516743433
- FDA 510(k) database K873088
Across registries
- FDA 510(k) K873088 decided 9 Sep 1987 Active
- FDA GUDID UDI-DI 05391516743433 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K873088
- Listed FDA GUDID 05391516743433
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 2325300
- Primary DI / UDI-DI
- 05391516743433
- 510(k) Number
- FDA product code
- LFX
- GMDN term
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3510
- GUDID distribution status
- In Commercial Distribution
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