Trinity Biotech 1206621
Trinity Biotech 1206621 is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K121565 on 8 Feb 2013 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516746359), 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 | Number05391516746359 | Date18 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121565 | Date8 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 05391516746359
- FDA 510(k) database K121565
Across registries
- FDA 510(k) K121565 decided 8 Feb 2013 Active
- FDA GUDID UDI-DI 05391516746359 listed 18 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K121565
- Listed FDA GUDID 05391516746359
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, control
- Model / Ref / Catalog
- 1206621
- Primary DI / UDI-DI
- 05391516746359
- 510(k) Number
- FDA product code
- MHJ
- GMDN term
- Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, control
- Device class
- Class II
- Regulation number
- 866.3220
- GUDID distribution status
- In Commercial Distribution
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