StaphTEX™ ST50

by Hardy Diagnostics

StaphTEX™ ST50 is a Class I device made by Hardy Diagnostics, listed in FDA GUDID since 23 Nov 2022 (UDI-DI 00819398028035), 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

Source GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00819398028035 UDI-DI	Date23 Nov 2022Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00819398028035

Coverage

1 jurisdiction

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Withdrawn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: ST50

Primary DI / UDI-DI: 00819398028035
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

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Properties

Single use
Convenience kit
Premarket exempt
Lot / batch number
Expiration date

Other properties (10, all answered No)