MHI · Class II · 21 CFR 866.3220

FDA Product Code MHI: Giardia Spp.

Leading manufacturers include Alexon, Inc., Ivd Research, Inc. and Techlab, Inc..

27
Total
27
Cleared
139d
Avg days
1991
Since
27 devices
25–27 of 27
Cleared Sep 27, 1991
PROSPEC T/GIARDIA RAPID ASSAY
K911337
Alexon, Inc.
Microbiology · 185d
Cleared Aug 12, 1991
CELLABS GIARDIA CEL I.F. TEST
K912152
Celltech Diagnostics , Ltd.
Microbiology · 89d
Cleared Jul 24, 1991
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408
Meridian Diagnostics, Inc.
Microbiology · 54d