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Trinity Biotech Premier Affinity A1c 500 - 1 kit

by Primus Corp.

Trinity Biotech Premier Affinity A1c 500 - 1 kit (09-03-0008) is a Class II device made by Primus Corp., listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516748124), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516748124 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  • Withdrawn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

Trade name
Trinity Biotech
Generic name
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Model / Ref / Catalog
Premier Affinity A1c 500 - 1 kit, 09-03-0008
Primary DI / UDI-DI
05391516748124
FDA product code
LCP
GMDN term
Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
Device class
Class II
Regulation number
864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

Similar devices in this category

Other devices filed under Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography.

Other devices from Primus Corp.

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Properties

  • Prescription use
  • Convenience kit
  • Combination product
Other properties (12, all answered No)