Home › Device types › GMI
Antigen, Cf And / Or Id, Coccidioides Immitis
FDA product code GMI · Class 2 · Microbiology
11
Registered devices
0
Adverse events
1
Recalls
11
510(k) clearances
Devices with this code
Coccidioides "F" Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC.Fungal Serology — MICROBIOLOGICS INC.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.Fungal Serology — MICROBIOLOGICS INC.IMMY — Immuno-Mycologics, Inc.Coccidioides "TP" Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.Coccidioides "F" Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC.IMMY — Immuno-Mycologics, Inc.
Recent 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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