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MHI — Giardia Spp. Class II

FDA Device Classification

FDA product code MHI covers "Giardia Spp.", a Class II medical device regulated under 21 CFR 866.3220. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MHI
Device Class
Class II
Regulation Number
866.3220
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K120001trinity biotechUNIGOLD GIARDIAMarch 1, 2013
K103673techlab inc., corporate research centerGIARDIA/ CRYPTOSPORIDIUM QUIK CHEKAugust 18, 2011
K081064ivd researchGIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFJanuary 14, 2009
K031942remelXPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020November 18, 2003
K031834remelXPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYNovember 10, 2003
K033274techlabGIARDIA IINovember 4, 2003
K024113ivd researchIVD CRYPTO/GIARDIA DFAMarch 5, 2003
K020583ivd researchIVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96September 17, 2002
K983399genzyme diagnosticsGIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYJanuary 11, 1999
K982711meridian diagnosticsPREMIER GIARDIANovember 25, 1998
K982245biosite incorporatedTRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE October 6, 1998
K963135techlabGIARDIA CELISANovember 29, 1996
K955897techlabCRYPTO/GIARDIA-CEL IF TESTAugust 5, 1996
K955157alexon biomedicalPROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAYFebruary 9, 1996
K952467trend scientificTREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)November 20, 1995
K953284trend scientificTREND GIARDIA DIRECT DETECTION RS TEST SYSTEMOctober 6, 1995
K944871lmd laboratoriesLMD GIARDIA ANTIGEN DETECTION ASSAYJune 22, 1995
K942098alexonPROSPECT GIARDIASeptember 9, 1994
K931147alexonPROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATIONMay 13, 1993
K930451alexonPROSPEC T GIARDIA MICROTITER ASSAYApril 21, 1993

FDA data resources