Trinity Biotech 2338571
Trinity Biotech 2338571 is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K935413 on 2 Jun 1994 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 05391516747172), 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 | Number05391516747172 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK935413 | Date2 Jun 1994 | StatusActive |
Official records
- AccessGUDID record 05391516747172
- FDA 510(k) database K935413
Across registries
- FDA 510(k) K935413 decided 2 Jun 1994 Active
- FDA GUDID UDI-DI 05391516747172 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K935413
- Listed FDA GUDID 05391516747172
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 2338571
- Primary DI / UDI-DI
- 05391516747172
- 510(k) Number
- FDA product code
- LLL
- GMDN term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5100
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA).