Trinity Biotech Tri-stat Liquid Controls Kit
by Primus Corp.
Trinity Biotech Tri-stat Liquid Controls Kit (03-06-0011) is a Class I device made by Primus Corp., listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516748216), 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 | Number05391516748216 | Date6 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 05391516748216
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Trinity Biotech
- Generic name
- Glycated haemoglobin (HbA1c) IVD, control
- Model / Ref / Catalog
- Tri-stat Liquid Controls Kit, 03-06-0011
- Primary DI / UDI-DI
- 05391516748216
- FDA product code
- JJX
- GMDN term
- Glycated haemoglobin (HbA1c) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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