GMIClass II

Antigen, Cf And / Or Id, Coccidioides Immitis

Microbiology · 21 CFR 866.3135

MDR events0All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances11All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Immuno-Mycologics, Inc
Open, ClassifiedMar 18, 2025
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Z-1389-2025 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

11 clearances for this product code