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Fungal Serology

MICROBIOLOGICS INC. · Model 200130 · UDI-DI 10634853000053

GMI
10
510(k) clearances
0
Adverse events
1
Recalls
2
Facilities

Description

Coccidioides immitis Antigen (F), 1mL

Recalls

DateFirmReason
2025-02-10Immuno-Mycologics, IncCandida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

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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.