Trinity Biotech 32-5100M
Trinity Biotech 32-5100M is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K894609 on 19 Sep 1989 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516746199), 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 | Number05391516746199 | Date18 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK894609 | Date19 Sep 1989 | StatusActive |
Official records
- AccessGUDID record 05391516746199
- FDA 510(k) database K894609
Across registries
- FDA 510(k) K894609 decided 19 Sep 1989 Active
- FDA GUDID UDI-DI 05391516746199 listed 18 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K894609
- Listed FDA GUDID 05391516746199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 32-5100M
- Primary DI / UDI-DI
- 05391516746199
- 510(k) Number
- FDA product code
- LSR
- GMDN term
- Multiple Borrelia species 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).
- ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM by ZEUS SCIENTIFIC, INC.
- FIAX LYME M TEST KIT by Whittaker Bioproducts, Inc.
- BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE by Bion Ent., Ltd.
- Borrelia B31 ViraChip IgM Test Kit by Viramed Biotech AG
- LYME FAST TEST by 3M COMPANY
- VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS by Viramed Biotech AG
- iDart Lyme IgG ImmunoBlot Kit by Id-Fish Technology, Inc.
- ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System by ZEUS SCIENTIFIC, INC.
- LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G) by Mrl Diagnostics
- Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit by Gold Standard Diagnostics, LLC