FDA Device Intelligence
Home › Device types › MDU

Antigen, Elisa, Cryptococcus

FDA product code MDU · Class 2 · Microbiology

2
Registered devices
0
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

IMMY — Immuno-Mycologics, Inc.PREMIER Cryptococcal Antigen — MERIDIAN BIOSCIENCE, INC.

Recent recalls

DateFirmReason
2018-12-17Meridian Bioscience IncAn enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results whe

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
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.