Skip to content

Trinity Biotech 2325461

by Clark Laboratories, Inc.

Trinity Biotech 2325461 is a medical device (FDA Class II; FDA product code MXJ, Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1) made by Clark Laboratories, Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 05391516747035), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516747035 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Trinity Biotech
Generic name
Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
2325461
Primary DI / UDI-DI
05391516747035
FDA product code
MXJ
GMDN term
Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3305
GUDID distribution status
In Commercial Distribution

Related devices

Category: Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices

Other devices filed under FDA product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1).

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)