Data / Medical devices / Multi-Analyte Controls Unassayed / United States

FDA-registered makers of Multi-Analyte Controls Unassayed in the United States: 31 establishments

Name: FDA-registered makers of Multi-Analyte Controls Unassayed in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

31 establishments in the United States are registered with the FDA to make Multi-Analyte Controls Unassayed (product code OHQ). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device: Multi-Analyte Controls Unassayed
Product code: OHQ
Country: United States

Makers of Multi-Analyte Controls Unassayed in the United States

Maker	Location	Role	Recall events	Source
Advin Biotech, Inc.	San Diego, CA, United States	Contract manufacturer	0	api.fda.gov
Aluris Sciences, LLC	Carlsbad, CA, United States	Contract manufacturer	0	api.fda.gov
Argonaut Manufacturing Services, Inc.	Carlsbad, CA, United States	Contract manufacturer	0	api.fda.gov
Astoria-Pacific, Inc.	Clackamas, OR, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Biochemical Diagnostics, Inc.	Edgewood, NY, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
Cepheid	Sunnyvale, CA, United States	Manufacturer, Manufacturer for export	0	api.fda.gov
Cepheid	Lodi, CA, United States	Manufacturer, Manufacturer for export	0	api.fda.gov
DSRV, Inc.	Mount Olive, NJ, United States	Manufacturer	0	api.fda.gov
DiaSorin Molecular LLC	Cypress, CA, United States	Manufacturer	0	api.fda.gov
Exact Diagnostics	Fort Worth, TX, United States	Manufacturer	0	api.fda.gov
Fort Worth Diagnostics LLC	Fort Worth, TX, United States	Manufacturer	0	api.fda.gov
Fujirebio Diagnostics, Inc.	Seguin, TX, United States	Manufacturer	0	api.fda.gov
Immunostics, Inc.	Eatontown, NJ, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
IMMY, Inc.	Norman, OK, United States	Manufacturer	0	api.fda.gov
Inova Diagnostics, Inc.	San Diego, CA, United States	Manufacturer	0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Milford, MA, United States	Manufacturer	0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Gaithersburg, MD, United States	Manufacturer	0	api.fda.gov
LGC Clinical Diagnostics, Inc.	Cumberland Foreside, ME, United States	Manufacturer	0	api.fda.gov
Maine Molecular Quality Controls, Inc.	Saco, ME, United States	Manufacturer	0	api.fda.gov
Medtox Diagnostics, Inc.	Burlington, NC, United States	Specification developer	0	api.fda.gov
Medtox Diagnostics, Inc.	Burlington, NC, United States	Specification developer	0	api.fda.gov
Meridian Bioscience, Inc.	Cincinnati, OH, United States	Manufacturer	0	api.fda.gov
Microbiologics, Inc.	Saint Cloud, MN, United States	Manufacturer	14	api.fda.gov
Microgenics Corporation	Fremont, CA, United States	Manufacturer	0	api.fda.gov
Oranoxis Inc	San Diego, CA, United States	Manufacturer, Manufacturer for export	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Athens, OH, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Sun Diagnostics, LLC	New Gloucester, ME, United States	Manufacturer	0	api.fda.gov
Zeptometrix LLC	Franklin, MA, United States	Manufacturer	0	api.fda.gov
Zeptometrix LLC.	Buffalo, NY, United States	Manufacturer	0	api.fda.gov

Updated November 2, 2026. 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.