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StaphTEX™ ST200

by Hardy Diagnostics

StaphTEX™ ST200 is a Class I device made by Hardy Diagnostics, listed in FDA GUDID since 23 Nov 2022 (UDI-DI 00819398028042), registry data as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819398028042 UDI-DI Date23 Nov 2022ListedStatusListed 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  • Withdrawn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
StaphTEX™
Generic name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Model / Ref / Catalog
ST200
Primary DI / UDI-DI
00819398028042
FDA product code
GTN
GMDN term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Device class
Class I
Regulation number
866.3700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

Similar devices in this category

Other devices filed under Staphylococcus aureus culture isolate antigen IVD, kit, agglutination.

Other devices from Hardy Diagnostics

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Properties

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