Skip to content

Trinity Biotech 2325301

by Clark Laboratories, Inc.

Trinity Biotech 2325301 is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K873088 on 9 Sep 1987 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 05391516747004), 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) K873088

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 Number05391516747004 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK873088 Date9 Sep 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K873088 decided 9 Sep 1987 Active
  • FDA GUDID UDI-DI 05391516747004 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K873088
  2. Listed FDA GUDID 05391516747004

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  • Withdrawn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
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
2325301
Primary DI / UDI-DI
05391516747004
510(k) Number
FDA product code
LFX
GMDN term
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3510
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K873088)

and 3 more cleared under K873088

Similar devices

Other devices filed under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).

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)