Trinity Biotech
Trinity Biotech (01-04-0015) is a Class II device made by Primus Corp., listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516744379), registry data as of 21 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 | Number05391516744379 | Date6 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05391516744379
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Glycated haemoglobin (HbA1c) IVD, control
- Model / Ref / Catalog
- HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit, 01-04-0015
- Primary DI / UDI-DI
- 05391516744379
- FDA product code
- JPK
- GMDN term
- Glycated haemoglobin (HbA1c) IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Glycated haemoglobin (HbA1c) IVD, control.
- ARCHITECT 4P52-11 04P5211 by Abbott
- MAS Diabetes Max-SP (Sample-Pack) B40000688 by Microgenics Corporation
- Diazyme DZ168C-CON by Diazyme Laboratories, Inc.
- BioHermes Glycohemoglobin Quality Control A1C-GE C01 A1C-C12 by Wuxi Biohermes Bio & Medical Technology Co., Ltd.
- Diazyme DZ168A-CON by Diazyme Laboratories, Inc.
- MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10X2) 4767 by SEBIA