MHIClass II

Giardia Spp.

21 CFR 866.3220 / Microbiology

MHI is the FDA product code for Giardia Spp., a class II device type, regulated under 21 CFR 866.3220. As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2013-03-01, and 6 recalls.

Classification record

Product code: MHI
Device name: Giardia Spp.
Regulation: 21 CFR 866.3220
Device class: Class II
Review panel: Microbiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 27
Ingested recalls: 6

Clearances, product code MHI

By decision year

27 clearances under product code MHI with a decision year between 1991 and 2013, 1992 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code MHI by decision year
Year	Clearances
1991	3
1992	4
1993	2
1994	1
1995	3
1996	3
1998	2
1999	1
2002	1
2003	4
2009	1
2011	1
2013	1

Applicants with the most clearances

Product code MHI

Applicants holding the most 510(k) clearances under product code MHI
Applicant	Clearances
Alexon, Inc.	8
IVD Research, LLC.	3
Techlab, Inc.	3
Meridian Diagnostics, Inc.	2
Trend Scientific, Inc.	2
Alexon Biomedical, Inc.	1
Biosite Incorporated	1
Celltech Diagnostics, Ltd.	1
Sekisui Diagnostics, LLC	1
Lmd Laboratories	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order