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StaphTEX™

HARDY DIAGNOSTICS · Model ST50 · UDI-DI 00819398028035

GTN
4
510(k) clearances
1
Adverse events
0
Recalls
7
Facilities

Description

StaphTEX™ Blue test kit, 50 tests. A rapid, latex agglutination slide-card test for the detection of coagulase clumping factor and/or protein A characteristics associated with Staphylococcus aureus.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.