Trinity Biotech 40-2023L
Trinity Biotech 40-2023L is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K950829 on 5 Jun 1996 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516747622), 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 | Number05391516747622 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950829 | Date5 Jun 1996 | StatusActive |
Official records
- AccessGUDID record 05391516747622
- FDA 510(k) database K950829
Across registries
- FDA 510(k) K950829 decided 5 Jun 1996 Active
- FDA GUDID UDI-DI 05391516747622 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K950829
- Listed FDA GUDID 05391516747622
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 40-2023L
- Primary DI / UDI-DI
- 05391516747622
- 510(k) Number
- FDA product code
- LSR
- GMDN term
- Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3830
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LSR (Reagent, Borrelia Serological Reagent).
- Anti-Borrelia burgdorferi US Westernblot (IgG) by EUROIMMUN US INC.
- HUMAN LYME IGM WESTERN BLOT KIT by Cambridge Diagnostics Ireland, Ltd.
- ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL by Boston Biomedica, Inc.
- Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack by Quidel Corp.
- LYME DISEASE MICROASSAY by Diamedix Corp.
- BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- VIDAS Lyme IgM by Biomerieux S.A.
- BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY by Medical Diagnostic Technologies, Inc.
- LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus by Diasorin Inc.
- Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit by Gold Standard Diagnostics, LLC