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Coccidioides "F" Antigen for Fungal Immunodiffusion

MERIDIAN BIOSCIENCE, INC. · Model 100405 · UDI-DI 00840733101045

GMI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Coccidioides immitis antigen reagents are standardized, purified preparations for the in vitro determination of precipitating antibodies to Coccidioides immitis (C. imm.). Reagents are available for detection of either “TP” (early) or “F” (late) antibodies. These reagents are optimized for use in the Ouchterlony double diffusion.

Recalls

Date	Firm	Reason
2025-02-10	Immuno-Mycologics, Inc	Candida 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.