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Trinity Biotech

by Primus Corp. 10 variants

Trinity Biotech (09-06-0046) is a Class II device made by Primus Corp., listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516748056), registry data as of 21 Oct 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 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516748056 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  • Withdrawn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, reagent
Model / Ref / Catalog
Premier Hb9210 HbA1c Analytical Column (1000), 09-06-0046
Primary DI / UDI-DI
05391516748056
FDA product code
LCP
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
Device class
Class II
Regulation number
864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagent

Similar devices in this category

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

Other devices from Primus Corp.

See all devices from Primus Corp. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)