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Trinity Biotech 31-8201

by Mardx Diagnostics, Inc.

Trinity Biotech 31-8201 is a Class II device made by Mardx Diagnostics, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 05391516747769), 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 Number05391516747769 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  • Withdrawn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 total antibody IVD, control
Model / Ref / Catalog
31-8201
Primary DI / UDI-DI
05391516747769
FDA product code
GMR
GMDN term
Treponema pallidum total antibody IVD, control
Device class
Class II
Regulation number
866.3830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Treponema pallidum total antibody IVD, control

Other devices from Mardx Diagnostics, Inc.

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Properties

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