MIZ · Class II · 21 CFR 866.3320

FDA Product Code MIZ: Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

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

2
Total
2
Cleared
323d
Avg days
1992
Since

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum Devices (Product Code MIZ)

2 devices
1–2 of 2
Cleared Jul 19, 2011
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
K101407
Immuno-Mycologics, Inc.
Microbiology · 426d
Cleared Jul 30, 1992
PERMIER HISTOPLASMA
K915700
Meridian Diagnostics, Inc.
Microbiology · 220d

About Product Code MIZ - Regulatory Context