Trinity Biotech 40-2017
Trinity Biotech 40-2017 is a Class II device made by Mardx Diagnostics, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516747646), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05391516747646 | Date19 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05391516747646
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Trinity Biotech
- Generic name
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 40-2017
- Primary DI / UDI-DI
- 05391516747646
- FDA product code
- LSR, LLL, JWL
- GMDN term
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.3830, 866.5100
- GUDID distribution status
- In Commercial Distribution
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