MDU · Class II · 21 CFR 866.3165

FDA Product Code MDU: Antigen, Elisa, Cryptococcus

Leading manufacturers include Immuno-Mycologics, Inc. and Meridian Diagnostics, Inc..

2
Total
2
Cleared
193d
Avg days
1991
Since

FDA 510(k) Cleared Antigen, Elisa, Cryptococcus Devices (Product Code MDU)

2 devices
1–2 of 2
Cleared Dec 17, 2012
ALPHA CRYPTOCOCCAL ANTIGEN EIA
K120946
Immuno-Mycologics, Inc.
Microbiology · 263d
Cleared Jan 25, 1991
PREMIER-CRYPTOCOCCAL ANTIGEN
K904393
Meridian Diagnostics, Inc.
Microbiology · 122d

About Product Code MDU - Regulatory Context