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Trinity Biotech B1029-70

by Mardx Diagnostics, Inc.

Trinity Biotech B1029-70 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 18 Sep 2016 (UDI-DI 05391516747950), 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 Number05391516747950 UDI-DI Date18 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 05391516747950 listed 18 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K833447
  2. Listed FDA GUDID 05391516747950

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  • Withdrawn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, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
B1029-70
Primary DI / UDI-DI
05391516747950
510(k) Number
FDA product code
MCB
GMDN term
Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Device class
Class I
Regulation number
866.2660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K833447)

Similar devices in this category

Other devices filed under Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA).

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)