GMJClass II

Antigens, Histoplasma Capsulatum, All

Microbiology · 21 CFR 866.3320

MDR events0All time

Recalls2All time

Registered firms5Currently listed

510(k) clearances12All 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

2 recall events for this product code

Immuno-Mycologics, Inc
TerminatedJun 20, 2016
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150
The device was found to have bacterial contamination.
Z-2040-2016 · View FDA record ↗
Immuno-Mycologics, Inc
TerminatedUnknown
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodi
False positive results due to potential contamination of reagent.
Z-2301-2020 · View FDA record ↗

Registered firms

5 firms currently registered for this product code

510(k) clearances

12 clearances for this product code