Trinity Biotech 1206611
Trinity Biotech 1206611 is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K120001 on 1 Mar 2013 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516746335), 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 | Number05391516746335 | Date18 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120001 | Date1 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 05391516746335
- FDA 510(k) database K120001
Across registries
- FDA 510(k) K120001 decided 1 Mar 2013 Active
- FDA GUDID UDI-DI 05391516746335 listed 18 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120001
- Listed FDA GUDID 05391516746335
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 1206611
- Primary DI / UDI-DI
- 05391516746335
- 510(k) Number
- FDA product code
- MHI
- GMDN term
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3220
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MHI (Giardia Spp.).
- PROSPECT(TM) GIARDIA RAPID ASSAY by Alexon, Inc.
- UNIGOLD GIARDIA by Trinity Biotech
- GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY by Genzyme Diagnostics
- PROSPECT GIARDIA CONTROLS by Alexon, Inc.
- PREMIER GIARDIA by Meridian Diagnostics, Inc.
- TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) by Trend Scientific, Inc.
- R2450020 by REMEL, INC.
- GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK by Techlab Inc., Corporate Research Center
- GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF by IVD RESEARCH, LLC.