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Trinity Biotech 2325861

by Clark Laboratories, Inc.

Trinity Biotech 2325861 is a Class I device made by Clark Laboratories, Inc., cleared under FDA 510(k) K980598 on 1 May 1998 and listed in FDA GUDID since 5 Nov 2019 (UDI-DI 05391516747103), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K980598

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516747103 UDI-DI Date5 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980598 Date1 May 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K980598 decided 1 May 1998 Active
  • FDA GUDID UDI-DI 05391516747103 listed 5 Nov 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K980598
  2. Listed FDA GUDID 05391516747103

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trinity Biotech
Generic name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
2325861
Primary DI / UDI-DI
05391516747103
510(k) Number
FDA product code
LLM
GMDN term
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class I
Regulation number
866.3235
GUDID distribution status
In Commercial Distribution

Related devices

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

Cleared under the same submission (K980598)

Similar devices

Other devices filed under FDA product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus).

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)