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Trinity Biotech 2325460

by Clark Laboratories, Inc.

Ref 2325460

Trinity Biotech 2325460 is an in vitro diagnostic device (EU IVDD general IVD; FDA Class II; FDA product code MXJ, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; EMDN category hsv 1 igm) made by Clark Laboratories, Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-05391516743488) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 05391516743488), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05391516743488 Basic UDI-DI 05391516743488UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516743488 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05391516743488 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 05391516743488 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05391516743488
  2. Registered EUDAMED B-05391516743488

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Captia HSV 1 IgM Test Kit EUDAMED
Trinity Biotech GUDID
Generic name
Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device name
Captia HSV 1 IgM Test Kit (96 Tests)
Model / Ref / Catalog
2325460
Primary DI / UDI-DI
05391516743488
Basic UDI-DI
B-05391516743488
FDA product code
MXJ
EMDN code
W0105040307 Hsv 1 igm
GMDN term
Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.3305
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: Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices in this category

Other devices filed under HERPES SIMPLEX 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)