Trinity Biotech 2338970
Trinity Biotech 2338970 is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K961764 on 19 Aug 1996 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516743891), 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 | Number05391516743891 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961764 | Date19 Aug 1996 | StatusActive |
Official records
- AccessGUDID record 05391516743891
- FDA 510(k) database K961764
Across registries
- FDA 510(k) K961764 decided 19 Aug 1996 Active
- FDA GUDID UDI-DI 05391516743891 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K961764
- Listed FDA GUDID 05391516743891
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 2338970
- Primary DI / UDI-DI
- 05391516743891
- 510(k) Number
- FDA product code
- MOB
- GMDN term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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