Data / Medical devices / Reagent, Coronavirus Serological / United States

FDA-registered makers of Reagent, Coronavirus Serological in the United States: 21 establishments

Name: FDA-registered makers of Reagent, Coronavirus Serological in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

21 establishments in the United States are registered with the FDA to make Reagent, Coronavirus Serological (product code QKO). 0 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device: Reagent, Coronavirus Serological
Product code: QKO
Country: United States

Makers of Reagent, Coronavirus Serological in the United States

Maker	Location	Role	Recall events	Source
Abbott Laboratories	Abbott Park, IL, United States	Manufacturer	0	api.fda.gov
Advin Biotech, Inc.	San Diego, CA, United States	Contract manufacturer	0	api.fda.gov
Access Bio, Inc.	Monroe Township, NJ, United States	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	1	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
Diasorin Inc.	Stillwater, MN, United States	Manufacturer, Manufacturer for export	0	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer	0	api.fda.gov
Diazyme Laboratories, Inc.	Poway, CA, United States	Manufacturer	0	api.fda.gov
Fujirebio Diagnostics, Inc.	Malvern, PA, United States	Contract manufacturer	0	api.fda.gov
Inbios International, Inc.	Seattle, WA, United States	Manufacturer	0	api.fda.gov
Lumiquick Diagnostics, Inc.	Santa Clara, CA, United States	Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor	0	api.fda.gov
Monobind, Inc.	Lake Forest, CA, United States	Manufacturer for export	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Rochester, NY, United States	Complaint file establishment, Manufacturer, Specification developer	2	api.fda.gov
Phamatech Inc.	San Diego, CA, United States	Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	0	api.fda.gov
Phase Diagnostics	Garden Grove, CA, United States	Manufacturer for export	0	api.fda.gov
Scantibodies Laboratory Inc.	San Diego, CA, United States	Contract manufacturer	0	api.fda.gov
Teco Diagnostics	Anaheim, CA, United States	Manufacturer for export	0	api.fda.gov
Trinity Biotech USA	Jamestown, NY, United States	Manufacturer for export	0	api.fda.gov
Zeus Scientific LLC	Branchburg, NJ, United States	Manufacturer	0	api.fda.gov

Updated November 3, 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.