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

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 Jan 14, 2009
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
K081064
Ivd Research, Inc.
Microbiology · 275d
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 Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113
Ivd Research, Inc.
Microbiology · 82d
Cleared Sep 17, 2002
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
K020583
Ivd Research, Inc.
Microbiology · 208d
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 Nov 20, 1995
TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
K952467
Trend Scientific, Inc.
Microbiology · 178d
Cleared Oct 06, 1995
TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
K953284
Trend Scientific, Inc.
Microbiology · 85d
Cleared Jun 22, 1995
LMD GIARDIA ANTIGEN DETECTION ASSAY
K944871
Lmd Laboratories
Microbiology · 262d
Cleared Sep 09, 1994
PROSPECT GIARDIA
K942098
Alexon, Inc.
Microbiology · 148d
Cleared May 13, 1993
PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION
K931147
Alexon, Inc.
Microbiology · 69d
Cleared Apr 21, 1993
PROSPEC T GIARDIA MICROTITER ASSAY
K930451
Alexon, Inc.
Microbiology · 84d
Cleared Sep 11, 1992
PROSPECT GIARDIA CONTROLS
K922675
Alexon, Inc.
Microbiology · 99d
Cleared Jun 19, 1992
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION
K922010
Alexon, Inc.
Microbiology · 50d
Cleared Apr 22, 1992
MODIFICATION PROSPECT GIARDIA RAPID ASSAY
K920817
Alexon, Inc.
Microbiology · 76d
Cleared Jan 30, 1992
PROSPECT(TM) GIARDIA RAPID ASSAY
K915093
Alexon, Inc.
Microbiology · 79d

About Product Code MHI - Regulatory Context