Data / Medical devices / Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus (GQG): 32 FDA-registered makers in 8 countries

Name: FDA-registered makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

32 establishments in 8 countries are registered with the FDA to make Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus (product code GQG, Class 1, 21 CFR 866.3480). 14 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on January 30, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GQG
Device class: 1
Regulation: 866.3480
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	17
China	4
Mexico	4
United Kingdom	2
South Korea	2
Canada	1
Italy	1
Taiwan	1

Makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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
BD Rapid Diagnostics (Suzhou) Co. Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area, China	Manufacturer	3	November 15, 2013	0	api.fda.gov
Becton, Dickinson & Co.	San Diego, CA, United States	Specification developer	3	November 15, 2013	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Manufacturer	3	November 15, 2013	1	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	San Diego, CA, United States	Specification developer	3	February 22, 2017	0	api.fda.gov
Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, United States	Manufacturer	3	February 22, 2017	0	api.fda.gov
Quidel Corp.	San Diego, CA, United States	Complaint file establishment, Manufacturer	3	February 22, 2017	0	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Scarborough, ME, United States	Manufacturer	1	October 21, 2003	2	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Westbrook, ME, United States	Manufacturer	1	October 21, 2003	0	api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.	Hangzhou Zhejiang, China	Manufacturer	1	January 30, 2026	0	api.fda.gov
Healgen Scientific LLC	Houston, TX, United States	Complaint file establishment, Manufacturer, Specification developer	1	November 20, 2002	0	api.fda.gov
Nano-Ditech Corporation	Cranbury, NJ, United States	Manufacturer	1	July 30, 2024	0	api.fda.gov
Oxoid, Ltd.	Basingstoke, Hampshire, United Kingdom	Exporter to the US, Specification developer	1	January 3, 1986	0	api.fda.gov
Response Biomedical Corp.	Vancouver British Columbia, Canada	Manufacturer	1	July 24, 2009	0	api.fda.gov
Sekisui Diagnostics, LLC	San Diego, CA, United States	Manufacturer for export, Repackager or relabeler	1	July 30, 2024	0	api.fda.gov
BIOSQUARE Inc.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Boditech Med Inc.	Chuncheon Gangwon, South Korea	Manufacturer	0		0	api.fda.gov
CTK Biotech, Inc.	Poway, CA, United States	Manufacturer for export	0		0	api.fda.gov
Diesse Diagnostica Senese S.P.A	MONTERIGGIONI Siena, Italy	Manufacturer	0		0	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer for export	0		0	api.fda.gov
Keva Inc.	Blaine, WA, United States	Manufacturer for export	0		0	api.fda.gov
Laboratorios Scantibodies S.A. De C.V.	TECATE Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.	shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Novem Medical S. De R.L. De C.V.	TIJUANA Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Panion & BF Biotech Inc. Xizhi Second Factory	New Taipei City, Taiwan	Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer	0		0	api.fda.gov
Planet Innovation Products, Inc.	Irvine, CA, United States	Contract manufacturer	0		0	api.fda.gov
Remel Europe Ltd	Dartford, Kent, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Remel, Inc.	Lenexa, KS, United States	Specification developer	0		0	api.fda.gov
SA Scientific, Ltd	San Antonio, TX, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
STS Corporation	Duluth, GA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Via Systems Manufacturas	Tijuana Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Zhejiang Orient Gene Biotech	Huzhou Zhejiang, China	Contract manufacturer	0		0	api.fda.gov

Updated January 30, 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.