Data / Medical devices / Coronavirus Antigen Detection Test System. / United States

FDA-registered makers of Coronavirus Antigen Detection Test System. in the United States: 35 establishments

Name: FDA-registered makers of Coronavirus Antigen Detection Test System. in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

35 establishments in the United States are registered with the FDA to make Coronavirus Antigen Detection Test System. (product code QKP). 0 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device: Coronavirus Antigen Detection Test System.
Product code: QKP
Country: United States

Makers of Coronavirus Antigen Detection Test System. in the United States

Maker	Location	Role	Recall events	Source
Advin Biotech, Inc.	San Diego, CA, United States	Manufacturer	0	api.fda.gov
Anp Technologies Inc	Newark, DE, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Azer Scientific, Inc.	Morgantown, PA, United States	Contract manufacturer	0	api.fda.gov
Azure Biotech Inc	Houston, TX, United States	Specification developer	0	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Scarborough, ME, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Westbrook, ME, United States	Manufacturer	0	api.fda.gov
Access Bio, Inc.	Monroe Township, NJ, United States	Manufacturer	0	api.fda.gov
Biosynchronicity Corporation	Bellevue, WA, United States	Manufacturer	0	api.fda.gov
Bioteke Usa LLC	Miami, FL, United States	Remanufacturer, Repackager or relabeler, Reprocessor	0	api.fda.gov
Breathh Inc	San Diego, CA, United States	Contract manufacturer	0	api.fda.gov
Biomerica	Irvine, CA, United States	Manufacturer for export	0	api.fda.gov
Chembio Diagnostic Systems, Inc.	Medford, NY, United States	Manufacturer for export	0	api.fda.gov
CTK Biotech, Inc.	Poway, CA, United States	Manufacturer for export	0	api.fda.gov
Chembio Diagnostic Systems	Bay Shore, NY, United States	Manufacturer for export	0	api.fda.gov
Genbody America, LLC	Jurupa Valley, CA, United States	Manufacturer	0	api.fda.gov
Inbios International, Inc.	Seattle, WA, United States	Manufacturer	0	api.fda.gov
Maxim Biomedical Inc.	Rockville, MD, United States	Manufacturer	0	api.fda.gov
Orasure Technologies Inc.	Bethlehem, PA, United States	Manufacturer	0	api.fda.gov
Orasure Technologies, Inc.	Bethlehem, PA, United States	Manufacturer	0	api.fda.gov
Orasure Technologies, Inc.	Bethlehem, PA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Manufacturer, Specification developer	1	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	San Diego, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, United States	Manufacturer	0	api.fda.gov
Princeton Biomeditech Corp.	Monmouth Jct, NJ, United States	Manufacturer	0	api.fda.gov
Princeton BioMeditech Corp.	Plainsboro, NJ, United States	Manufacturer	0	api.fda.gov
Princeton BioMeditech Corp.	Skillman, NJ, United States	Manufacturer	0	api.fda.gov
Quidel Corp.	San Diego, CA, United States	Manufacturer	1	api.fda.gov
Scantibodies Laboratory Inc.	San Diego, CA, United States	Contract manufacturer	0	api.fda.gov
Scantibodies Laboratory, Inc.	Santee, CA, United States	Contract manufacturer	0	api.fda.gov
Sekisui Diagnostics, LLC	San Diego, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer	1	api.fda.gov
True Diagnostics, Inc.	Carlsbad, CA, United States	Contract manufacturer, Manufacturer for export	0	api.fda.gov
Watmind Usa	Jackson, MS, United States	Complaint file establishment, Specification developer	0	api.fda.gov
iHealth Manufacturing Inc	Irwindale, CA, United States	Contract 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.