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Antigens, Histoplasma Capsulatum, All
FDA product code GMJ · Class 2 · Microbiology
12
Registered devices
0
Adverse events
2
Recalls
12
510(k) clearances
Devices with this code
IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.Histoplasma Antigen for Fungal Immunodiffusion — MERIDIAN BIOSCIENCE, INC.Fungal Serology — MICROBIOLOGICS INC.Fungal Serology — MICROBIOLOGICS INC.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.IMMY — Immuno-Mycologics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-04 | Immuno-Mycologics, Inc | False positive results due to potential contamination of reagent. |
| 2016-05-09 | Immuno-Mycologics, Inc | The device was found to have bacterial contamination. |
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