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IMMY

Immuno-Mycologics, Inc. · Model CRY101 · UDI-DI 00816387020759

MDU Prescription
2
510(k) clearances
0
Adverse events
1
Recalls
4
Facilities

Description

Cryptococcus Antigen EIA

Recalls

DateFirmReason
2018-12-17Meridian Bioscience IncAn enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patien

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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.