Trinity Biotech 40-2019C
Trinity Biotech 40-2019C is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K951709 on 7 Jun 1996 (1 earlier submission) and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516747653), 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 | Number05391516747653 | Date18 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK951709 | Date7 Jun 1996 | StatusActive |
Official records
- AccessGUDID record 05391516747653
- FDA 510(k) database K951709
- FDA 510(k) database K950829
Across registries
- FDA 510(k) K951709 decided 7 Jun 1996 Active
- FDA GUDID UDI-DI 05391516747653 listed 18 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K950829
- Cleared FDA 510(k) K951709
- Listed FDA GUDID 05391516747653
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 40-2019C
- Primary DI / UDI-DI
- 05391516747653
- FDA product code
- LSR
- GMDN term
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3830
- GUDID distribution status
- In Commercial Distribution
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