Data / Medical devices / Reagents, 2019-Novel Coronavirus Nucleic Acid / United States

FDA-registered makers of Reagents, 2019-Novel Coronavirus Nucleic Acid in the United States: 30 establishments

Name: FDA-registered makers of Reagents, 2019-Novel Coronavirus Nucleic Acid in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

30 establishments in the United States are registered with the FDA to make Reagents, 2019-Novel Coronavirus Nucleic Acid (product code QJR). 0 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

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Device: Reagents, 2019-Novel Coronavirus Nucleic Acid
Product code: QJR
Country: United States

Makers of Reagents, 2019-Novel Coronavirus Nucleic Acid in the United States

Maker	Location	Role	Recall events	Class I	Source
Abbott Molecular, Inc.	Des Plaines, IL, United States	Manufacturer	4	1	api.fda.gov
Aptitude Medical Systems	Goleta, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	0	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Scarborough, ME, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0	0	api.fda.gov
Abbott Molecular Distribution Center	Itasca, IL, United States	Manufacturer	0	0	api.fda.gov
Access Bio, Inc.	Monroe Township, NJ, United States	Manufacturer	0	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Manufacturer, Specification developer	4	0	api.fda.gov
Biogx	Birmingham, AL, United States	Manufacturer	0	0	api.fda.gov
BioFire Defense, LLC	Salt Lake City, UT, United States	Manufacturer	0	0	api.fda.gov
Cepheid	Sunnyvale, CA, United States	Manufacturer, Manufacturer for export	0	0	api.fda.gov
Codiagnostics	Salt Lake City, UT, United States	Manufacturer for export	0	0	api.fda.gov
CTK Biotech, Inc.	Poway, CA, United States	Manufacturer for export	0	0	api.fda.gov
Cepheid	Lodi, CA, United States	Manufacturer	0	0	api.fda.gov
DiaSorin Molecular LLC	Cypress, CA, United States	Manufacturer	2	0	api.fda.gov
Genmark Diagnostics, Inc.	Carlsbad, CA, United States	Manufacturer	0	0	api.fda.gov
Healgen Scientific LLC	Houston, TX, United States	Complaint file establishment, Specification developer	0	0	api.fda.gov
Hologic, Inc.	San Diego, CA, United States	Manufacturer	0	0	api.fda.gov
Inbios International, Inc.	Seattle, WA, United States	Manufacturer	0	0	api.fda.gov
Ivd Research, LLC.	Carlsbad, CA, United States	Contract manufacturer	0	0	api.fda.gov
Life Technologies Corporation	Austin, TX, United States	Contract manufacturer	0	0	api.fda.gov
Life Technologies Corporation	S San Fran, CA, United States	Specification developer	0	0	api.fda.gov
Life Technologies Corporation	Pleasanton, CA, United States	Manufacturer	1	0	api.fda.gov
Life Technologies Corporation	Frederick, MD, United States	Contract manufacturer	0	0	api.fda.gov
Meridian Bioscience, Inc.	Cincinnati, OH, United States	Manufacturer	2	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Athens, OH, United States	Complaint file establishment, Manufacturer	2	1	api.fda.gov
Roche Molecular Systems, Inc.	Branchburg, NJ, United States	Manufacturer, Manufacturer for export	1	0	api.fda.gov
Roche Molecular Systems, Inc.	Pleasanton, CA, United States	Specification developer	0	0	api.fda.gov
Rpi Biosolutions	Mundelein, IL, United States	Contract manufacturer	0	0	api.fda.gov
Spectrum Solutions LLC	Draper, UT, United States	Manufacturer	0	0	api.fda.gov
Tetracore, Inc	Potomac, MD, United States	Manufacturer	0	0	api.fda.gov
Visby Medical, Inc.	San Jose, CA, United States	Complaint file establishment, Manufacturer	1	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.