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Trinity Biotech 40-2027L

by Mardx Diagnostics, Inc.

Trinity Biotech 40-2027L is a Class II device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K950829 on 5 Jun 1996 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516747639), 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) K950829

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 Number05391516747639 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK950829 Date5 Jun 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K950829 decided 5 Jun 1996 Active
  • FDA GUDID UDI-DI 05391516747639 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K950829
  2. Listed FDA GUDID 05391516747639

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  • Withdrawn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 antigen IVD, control
Model / Ref / Catalog
40-2027L
Description
40-2027L B. burgdorferi WB Weakly Reactive IgG Control, 120µL
Primary DI / UDI-DI
05391516747639
510(k) Number
FDA product code
LSR
GMDN term
Borrelia burgdorferi antigen IVD, control
Device class
Class II
Regulation number
866.3830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Borrelia burgdorferi antigen IVD, control

Cleared under the same submission (K950829)

and 5 more cleared under K950829

Similar devices

Also classified as Borrelia burgdorferi antigen IVD, control.

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)