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Trinity Biotech 31-8100

by Mardx Diagnostics, Inc.

Trinity Biotech 31-8100 is a Class II device made by Mardx Diagnostics, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516745673), 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 Number05391516745673 UDI-DI Date19 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  • Withdrawn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
Treponema pallidum antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
31-8100
Primary DI / UDI-DI
05391516745673
FDA product code
GMS
GMDN term
Treponema pallidum antigen IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.3830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Treponema pallidum antigen IVD, kit, fluorescent immunoassay

Similar devices

Other devices filed under FDA product code GMS (Anti-Human Globulin, Fta-Abs Test).

Other devices from Mardx Diagnostics, Inc.

See all devices from Mardx Diagnostics, Inc. →

Properties

  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)