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Trinity Biotech 2325760

by Clark Laboratories, Inc.

Ref 2325760

Trinity Biotech 2325760 is a device classified as IVD General (EU), Class I (US) made by Clark Laboratories, Inc., registered in EUDAMED on 25 Jul 2026 (Basic UDI-DI B-05391516743556), cleared under FDA 510(k) K980596 on 22 Jul 1998 and listed in FDA GUDID since 25 Oct 2019 (UDI-DI 05391516743556), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K980596

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05391516743556 Basic UDI-DI 05391516743556UDI-DIDate25 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516743556 UDI-DI Date25 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK980596 Date22 Jul 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05391516743556 registered 25 Jul 2026 Active
  • FDA 510(k) K980596 decided 22 Jul 1998 Active
  • FDA GUDID UDI-DI 05391516743556 listed 25 Oct 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K980596
  2. Listed FDA GUDID 05391516743556
  3. Registered EUDAMED B-05391516743556

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  • Withdrawn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 EBV-VCA IgM Test Kit EUDAMED
Trinity Biotech GUDID
Generic name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device name
Captia EBV-VCA IgM (96 tests)
Model / Ref / Catalog
2325760
Primary DI / UDI-DI
05391516743556
Basic UDI-DI
B-05391516743556
510(k) Number
FDA product code
LSE
EMDN code
W010504040104 Ebv vca igm
GMDN term
Epstein-Barr virus (EBV) immunoglobulin M (IgM) 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 M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K980596)

Similar devices in this category

Other devices filed under EPSTEIN BARR VIRUS.

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)