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Trinity Biotech 44-5017

by Mardx Diagnostics, Inc.

Trinity Biotech 44-5017 is a medical device (FDA Class II; FDA product code LSR, Reagent, Borrelia Serological Reagent) made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K951709 on 7 Jun 1996 (1 earlier submission) and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516747707), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516747707 UDI-DI Date18 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951709 Date7 Jun 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951709 decided 7 Jun 1996 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05391516747707 listed 18 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K950829
  2. Cleared FDA 510(k) K951709
  3. Listed FDA GUDID 05391516747707

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  • Withdrawn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 G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
44-5017
Primary DI / UDI-DI
05391516747707
510(k) Number
FDA product code
LSR
GMDN term
Borrelia burgdorferi immunoglobulin G (IgG)/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 G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K950829)

and 5 more cleared under K950829

Cleared under the same submission (K951709)

and 5 more cleared under K951709

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