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Trinity Biotech 40-6196P

by Mardx Diagnostics, Inc.

Trinity Biotech 40-6196P is a Class I device made by Mardx Diagnostics, Inc., listed in FDA GUDID since 18 Sep 2016 (UDI-DI 05391516747899), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391516747899 UDI-DI Date18 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Trinity Biotech
Generic name
Bordetella pertussis total antibody IVD, kit, immunoblot
Model / Ref / Catalog
40-6196P
Primary DI / UDI-DI
05391516747899
FDA product code
GOX
GMDN term
Bordetella pertussis total antibody IVD, kit, immunoblot
Device class
Class I
Regulation number
866.3065
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bordetella pertussis total antibody IVD, kit, immunoblot

Similar devices

Other devices filed under FDA product code GOX (Antigen, B. Pertussis).

Other devices from Mardx Diagnostics, Inc.

See all devices from Mardx Diagnostics, Inc. →

Properties

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