Product Code: MHI FDA class 2 21 CFR 866.3220

Giardia Spp.

Microbiology

The Giardia Spp. device is an in vitro diagnostic test used to detect Giardia species, intestinal parasites responsible for giardiasis, a common waterborne diarrheal illness, in stool or other biological specimens. It is classified as a Class 2 device under 21 CFR 866.3220, which covers serological reagents, and requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The device falls under the Microbiology medical specialty and is subject to general controls and special controls. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MHI
Device Class: FDA class 2
Regulation Number: 866.3220
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K120001	UNIGOLD GIARDIA	Mar 01, 2013	Substantially Equivalent	Trinity Biotech
K103673	GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK	Aug 18, 2011	Substantially Equivalent	Techlab Inc., Corporate Research Center
K081064	GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF	Jan 14, 2009	Substantially Equivalent	Ivd Research, Inc.
K031942	XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020	Nov 18, 2003	Substantially Equivalent	Remel, Inc.
K031834	XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY	Nov 10, 2003	Substantially Equivalent	Remel, Inc.
K033274	GIARDIA II	Nov 04, 2003	Substantially Equivalent	Techlab, Inc.
K024113	IVD CRYPTO/GIARDIA DFA	Mar 05, 2003	Substantially Equivalent	Ivd Research, Inc.
K020583	IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96	Sep 17, 2002	Substantially Equivalent	Ivd Research, Inc.
K983399	GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY	Jan 11, 1999	Substantially Equivalent	Genzyme Diagnostics
K982711	PREMIER GIARDIA	Nov 25, 1998	Substantially Equivalent	Meridian Diagnostics, Inc.
K982245	TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA	Oct 06, 1998	Substantially Equivalent	Biosite Incorporated
K963135	GIARDIA CELISA	Nov 29, 1996	Substantially Equivalent	Techlab, Inc.
K955897	CRYPTO/GIARDIA-CEL IF TEST	Aug 05, 1996	Substantially Equivalent	Techlab, Inc.
K955157	PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY	Feb 09, 1996	Substantially Equivalent	Alexon Biomedical, Inc.
K952467	TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)	Nov 20, 1995	Substantially Equivalent	Trend Scientific, Inc.
K953284	TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM	Oct 06, 1995	Substantially Equivalent	Trend Scientific, Inc.
K944871	LMD GIARDIA ANTIGEN DETECTION ASSAY	Jun 22, 1995	Substantially Equivalent	Lmd Laboratories
K942098	PROSPECT GIARDIA	Sep 09, 1994	Substantially Equivalent	Alexon, Inc.
K931147	PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION	May 13, 1993	Substantially Equivalent	Alexon, Inc.
K930451	PROSPEC T GIARDIA MICROTITER ASSAY	Apr 21, 1993	Substantially Equivalent	Alexon, Inc.
K922675	PROSPECT GIARDIA CONTROLS	Sep 11, 1992	Substantially Equivalent	Alexon, Inc.
K922010	PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION	Jun 19, 1992	Substantially Equivalent	Alexon, Inc.
K920817	MODIFICATION PROSPECT GIARDIA RAPID ASSAY	Apr 22, 1992	Substantially Equivalent	Alexon, Inc.
K915093	PROSPECT(TM) GIARDIA RAPID ASSAY	Jan 30, 1992	Substantially Equivalent	Alexon, Inc.
K911337	PROSPEC T/GIARDIA RAPID ASSAY	Sep 27, 1991	Substantially Equivalent	Alexon, Inc.
K912152	CELLABS GIARDIA CEL I.F. TEST	Aug 12, 1991	Substantially Equivalent	Celltech Diagnostics , Ltd.
K912408	MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA	Jul 24, 1991	Substantially Equivalent	Meridian Diagnostics, Inc.