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Trinity Biotech Tri-stat Reagent Kit

by Primus Corp.

Trinity Biotech Tri-stat Reagent Kit (03-06-0010) is a Class II device made by Primus Corp., cleared under FDA 510(k) K062658 on 26 Nov 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05391516748223), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K062658

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516748223 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062658 Date26 Nov 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062658 decided 26 Nov 2007 Active
  • FDA GUDID UDI-DI 05391516748223 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062658
  2. Listed FDA GUDID 05391516748223

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trinity Biotech
Generic name
Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
Tri-stat Reagent Kit, 03-06-0010
Primary DI / UDI-DI
05391516748223
510(k) Number
FDA product code
LCP
GMDN term
Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K062658)

Similar devices

Other devices filed under FDA product code LCP (Assay, Glycosylated Hemoglobin).

Other devices from Primus Corp.

See all devices from Primus Corp. →

Properties

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