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Trinity Biotech B1029-70B

by Mardx Diagnostics, Inc.

Trinity Biotech B1029-70B is a Class I device made by Mardx Diagnostics, Inc., cleared under FDA 510(k) K833447 on 21 May 1984 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516748841), 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) K833447

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 Number05391516748841 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK833447 Date21 May 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K833447 decided 21 May 1984 Active
  • FDA GUDID UDI-DI 05391516748841 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K833447
  2. Listed FDA GUDID 05391516748841

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  • Withdrawn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
Clostridium difficile antigen IVD, reagent
Model / Ref / Catalog
B1029-70B
Primary DI / UDI-DI
05391516748841
510(k) Number
FDA product code
MCB
GMDN term
Clostridium difficile antigen IVD, reagent
Device class
Class I
Regulation number
866.2660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Clostridium difficile antigen IVD, reagent

Cleared under the same submission (K833447)

Similar devices

Also classified as Clostridium difficile antigen IVD, reagent.

Similar devices

Other devices filed under FDA product code MCB (Antigen, C. Difficile).

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)