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Trinity Biotech G5888

by Clark Laboratories, Inc.

Ref G5888

Trinity Biotech G5888 is a device classified as IVD General (EU), Class II (US) made by Clark Laboratories, Inc., registered in EUDAMED on 25 Jul 2026 (Basic UDI-DI B-05391516743143), cleared under FDA 510(k) K802568 on 12 Nov 1980 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516743143), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K802568

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05391516743143 Basic UDI-DI 05391516743143UDI-DIDate25 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516743143 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK802568 Date12 Nov 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05391516743143 registered 25 Jul 2026 Active
  • FDA 510(k) K802568 decided 12 Nov 1980 Active
  • FDA GUDID UDI-DI 05391516743143 listed 19 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K802568
  2. Listed FDA GUDID 05391516743143
  3. Registered EUDAMED B-05391516743143

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
G-6-PDH Control, Deficient EUDAMED
Trinity Biotech GUDID
Generic name
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Device name
G-6-PDH Control, Deficient G5888, 6 x 0.5 mL
Model / Ref / Catalog
G5888
Primary DI / UDI-DI
05391516743143
Basic UDI-DI
B-05391516743143
510(k) Number
FDA product code
KHG
EMDN code
W0101050201 Enzyme controls
GMDN term
Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.7500
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

Cleared under the same submission (K802568)

Similar devices in this category

Other devices filed under ENZYME CONTROLS.

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Contains human tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)