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Trinity Biotech Mobile Phase 2 Reagent - 3.8L

by Primus Corp.

Trinity Biotech Mobile Phase 2 Reagent - 3.8L (01-03-0041) is a Class II device made by Primus Corp., cleared under FDA 510(k) K955283 on 1 Mar 1996 and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516744249), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K955283

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 Number05391516744249 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955283 Date1 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955283 decided 1 Mar 1996 Active
  • FDA GUDID UDI-DI 05391516744249 listed 6 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0321-2021 FDA Class II initiated 9 Oct 2020

    The product did not receive pre-market approval or clearance.

Timeline

3 dated events

  1. Cleared FDA 510(k) K955283
  2. Listed FDA GUDID 05391516744249
  3. Recall initiated FDA recalls Z-0321-2021

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  • Withdrawn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
Multiple haemoglobin subtype IVD, reagent
Model / Ref / Catalog
Mobile Phase 2 Reagent - 3.8L, 01-03-0041
Primary DI / UDI-DI
05391516744249
510(k) Number
FDA product code
GKA
GMDN term
Multiple haemoglobin subtype IVD, reagent
Device class
Class II
Regulation number
864.7415
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3.8 Liter

Related devices

Category: Multiple haemoglobin subtype IVD, reagent

Cleared under the same submission (K955283)

and 8 more cleared under K955283

Similar devices

Other devices filed under FDA product code GKA (Abnormal Hemoglobin Quantitation).

Other devices from Primus Corp.

See all devices from Primus Corp. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)