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St2 Assay

FDA product code OYG · Class 2 · Clinical Chemistry

0
Registered devices
0
Adverse events
1
Recalls
1
510(k) clearances

Recent recalls

DateFirmReason
2012-02-28Critical DiagnosticsThe recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage S

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.