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Trinity Biotech

by Primus Corp. 10 variants

Trinity Biotech (01-04-0018) is a Class II device made by Primus Corp., listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516744812), registry data as of 8 Jun 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516744812 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Glycated haemoglobin (HbA1c) IVD, calibrator
Model / Ref / Catalog
HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit, 01-04-0018
Primary DI / UDI-DI
05391516744812
FDA product code
JPK
GMDN term
Glycated haemoglobin (HbA1c) IVD, calibrator
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, calibrator

Similar devices in this category

Other devices filed under Glycated haemoglobin (HbA1c) IVD, calibrator.

Other devices from Primus Corp.

See all devices from Primus Corp. →

Properties

  • Prescription use
  • Convenience kit
  • HCT/P
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)