FDA Device Intelligence
Home › Immuno-Mycologics, Inc. › IMMY

IMMY

Immuno-Mycologics, Inc. · Model QDXH70 · UDI-DI 00816387020599

GMJ Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
2
Facilities

Description

Histoplasma Mycelial CF Antigen

Recalls

DateFirmReason
2019-11-04Immuno-Mycologics, IncFalse positive results due to potential contamination of reagent.
2016-05-09Immuno-Mycologics, IncThe device was found to have bacterial contamination.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.