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Trinity Biotech 2325801

by Clark Laboratories, Inc.

Ref 2325801

Trinity Biotech 2325801 is a device classified as IVD General (EU), Class I (US) made by Clark Laboratories, Inc., registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI B-05391516747097), cleared under FDA 510(k) K951549 on 29 Apr 1996 and listed in FDA GUDID since 5 Nov 2019 (UDI-DI 05391516747097), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K951549

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05391516747097 Basic UDI-DI 05391516747097UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516747097 UDI-DI Date5 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK951549 Date29 Apr 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05391516747097 registered 24 Jul 2026 Active
  • FDA 510(k) K951549 decided 29 Apr 1996 Active
  • FDA GUDID UDI-DI 05391516747097 listed 5 Nov 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K951549
  2. Listed FDA GUDID 05391516747097
  3. Registered EUDAMED B-05391516747097

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  • Withdrawn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
Captia EBNA-1 IgG Test Kit EUDAMED
Trinity Biotech GUDID
Generic name
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device name
Captia EBNA-1 IgG Test Kit (480 Tests)
Model / Ref / Catalog
2325801
Primary DI / UDI-DI
05391516747097
Basic UDI-DI
B-05391516747097
510(k) Number
FDA product code
LLM
EMDN code
W010504040106 Ebv ebna igg
GMDN term
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.3235
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 I

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

Related devices

Category: Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K951549)

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)