Trinity Biotech 2325900
Trinity Biotech 2325900 is a Class I device made by Clark Laboratories, Inc., cleared under FDA 510(k) K897006 on 26 Jul 1990 and listed in FDA GUDID since 25 Oct 2019 (UDI-DI 05391516743600), 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 | Number05391516743600 | Date25 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK897006 | Date26 Jul 1990 | StatusActive |
Official records
- AccessGUDID record 05391516743600
- FDA 510(k) database K897006
Across registries
- FDA 510(k) K897006 decided 26 Jul 1990 Active
- FDA GUDID UDI-DI 05391516743600 listed 25 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K897006
- Listed FDA GUDID 05391516743600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 2325900
- Primary DI / UDI-DI
- 05391516743600
- 510(k) Number
- FDA product code
- LJY
- GMDN term
- Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class I
- Regulation number
- 866.3380
- GUDID distribution status
- In Commercial Distribution