Giardia Spp. (MHI): 15 FDA-registered makers in 4 countries

Name: FDA-registered makers of Giardia Spp.
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

15 establishments in 4 countries are registered with the FDA to make Giardia Spp. (product code MHI, Class 2, 21 CFR 866.3220). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on March 1, 2013, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: MHI
Device class: 2
Regulation: 866.3220
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	11
United Kingdom	2
Mexico	1
Germany	1

Makers of Giardia Spp.

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Oxoid, Ltd.	Basingstoke, Hampshire, United Kingdom	Exporter to the US, Specification developer	3	November 18, 2003	0	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer	2	March 5, 2003	0	api.fda.gov
Medical Chemical Corporation	Torrance, CA, United States	Manufacturer, Repackager or relabeler	2	March 5, 2003	0	api.fda.gov
Remel, Inc.	Lenexa, KS, United States	Manufacturer	2	November 18, 2003	3	api.fda.gov
Techlab, Inc.	Radford, VA, United States	Manufacturer	2	August 18, 2011	0	api.fda.gov
Techlab, Inc.	Blacksburg, VA, United States	Manufacturer	2	August 18, 2011	0	api.fda.gov
Sekisui Diagnostics, LLC	San Diego, CA, United States	Manufacturer, Repackager or relabeler	1	January 11, 1999	1	api.fda.gov
Aceso Laboratories Inc.	Chino, CA, United States	Manufacturer	0		0	api.fda.gov
Biomerica De Mexico, S.A. De C.V.	MEXICALI Baja California, Mexico	Manufacturer	0		0	api.fda.gov
DRG Instruments GMBH	MARBURG Hesse, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Epitope Diagnostics, Inc.	San Diego, CA, United States	Manufacturer	0		0	api.fda.gov
Immunocentrix Corporation	Canoga Park, CA, United States	Manufacturer for export	0		0	api.fda.gov
Ivd Research, LLC.	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Meridian Bioscience, Inc.	Cincinnati, OH, United States	Manufacturer	0		0	api.fda.gov
Remel Europe Ltd	Dartford, Kent, United Kingdom	Contract manufacturer, Manufacturer	0		0	api.fda.gov

Updated March 1, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.