Trinity Biotech 305-10
by Trinity Biotech Public Limited Company
Trinity Biotech 305-10 is a Class II device made by Trinity Biotech Public Limited Company, cleared under FDA 510(k) K854245 on 22 Jan 1986 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 05391516746014), 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 | Number05391516746014 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK854245 | Date22 Jan 1986 | StatusActive |
Official records
- AccessGUDID record 05391516746014
- FDA 510(k) database K854245
Across registries
- FDA 510(k) K854245 decided 22 Jan 1986 Active
- FDA GUDID UDI-DI 05391516746014 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K854245
- Listed FDA GUDID 05391516746014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trinity Biotech
- Generic name
- Angiotensin converting enzyme (ACE) IVD, reagent
- Model / Ref / Catalog
- 305-10
- Primary DI / UDI-DI
- 05391516746014
- 510(k) Number
- FDA product code
- KQN
- GMDN term
- Angiotensin converting enzyme (ACE) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1090
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KQN (Radioassay, Angiotensin Converting Enzyme).
- ANGIOTENSIN CONVERTING ENZYME ASSAY SYS by Ventrex Laboratories, Inc.
- ACE COLOR TEST by Hana Biologics, Inc.
- ALDOSTERONE DIRECT RIA KIT by Biotecx Laboratories, Inc.
- THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT by Thermo-Electron Corp.
- BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY by American Laboratory Products Company
- SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV by Sigma Diagnostics, Inc.
- ANGIOTENSIN CONVERTING ENZYME REA by American Laboratory Products Company
- ACE ACTIVITY MICROVIAL TEST SET by Ventrex Laboratories, Inc.
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