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Trinity Biotech 40-8696M/J

by Mardx Diagnostics, Inc.

Trinity Biotech 40-8696M/J is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K894293 on 21 Aug 1989 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516746281), 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) K894293

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 Number05391516746281 UDI-DI Date18 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK894293 Date21 Aug 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K894293 decided 21 Aug 1989 Active
  • FDA GUDID UDI-DI 05391516746281 listed 18 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K894293
  2. Listed FDA GUDID 05391516746281

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  • Withdrawn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
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
40-8696M/J
Primary DI / UDI-DI
05391516746281
510(k) Number
FDA product code
LSR
GMDN term
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K894293)

Similar devices

Other devices filed under FDA product code LSR (Reagent, Borrelia Serological Reagent).

Other devices from Mardx Diagnostics, Inc.

See all devices from Mardx Diagnostics, Inc. →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)