MHI · Class II · 21 CFR 866.3220

FDA Product Code MHI: Giardia Spp.

Leading manufacturers include Techlab, Inc., Remel, Inc. and Meridian Diagnostics, Inc..

27
Total
27
Cleared
139d
Avg days
1991
Since

FDA 510(k) Cleared Giardia Spp. Devices (Product Code MHI)

27 devices
1–24 of 27
Cleared Mar 01, 2013
UNIGOLD GIARDIA
K120001
Trinity Biotech
Microbiology · 423d
Cleared Aug 18, 2011
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K103673
Techlab Inc., Corporate Research Center
Microbiology · 245d
Cleared Nov 18, 2003
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942
Remel, Inc.
Microbiology · 147d
Cleared Nov 10, 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834
Remel, Inc.
Microbiology · 150d
Cleared Nov 04, 2003
GIARDIA II
K033274
Techlab, Inc.
Microbiology · 25d
Cleared Jan 11, 1999
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399
Genzyme Diagnostics
Microbiology · 105d
Cleared Nov 25, 1998
PREMIER GIARDIA
K982711
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Oct 06, 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
K982245
Biosite Incorporated
Microbiology · 102d
Cleared Nov 29, 1996
GIARDIA CELISA
K963135
Techlab, Inc.
Microbiology · 109d
Cleared Aug 05, 1996
CRYPTO/GIARDIA-CEL IF TEST
K955897
Techlab, Inc.
Microbiology · 223d
Cleared Feb 09, 1996
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
K955157
Alexon Biomedical, Inc.
Microbiology · 88d
Cleared Jul 24, 1991
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408
Meridian Diagnostics, Inc.
Microbiology · 54d

About Product Code MHI - Regulatory Context