Product Code: GQG FDA class 1 21 CFR 866.3480

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

Microbiology

The Antigen, CF (Including CF Controls), Respiratory Syncytial Virus is a complement fixation (CF) antigen and associated control reagent used in laboratory testing to detect antibodies against RSV in patient serum. It is an FDA Class 1 device subject only to general controls, representing the lowest regulatory risk tier and requiring no premarket approval or 510(k). Regulated under 21 CFR 866.3480, it carries product code GQG and belongs to the Microbiology specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code GQG in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: GQG
Device Class: FDA class 1
Regulation Number: 866.3480
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253318	Clungene RSV Antigen Rapid Test	Jan 30, 2026	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.
K240280	Nano-Check RSV Test	Jul 30, 2024	Substantially Equivalent	Nano-Ditech Corporation
K162911	Sofia RSV FIA on Sofia 2 analyzer	Feb 22, 2017	Substantially Equivalent	Quidel Corporation
K133140	BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV	Nov 15, 2013	Substantially Equivalent	Becton, Dickinson & CO
K132456	BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV	Nov 07, 2013	Substantially Equivalent	Becton, Dickinson and Company
K130398	SOFIA(R) RSV FIA	Aug 13, 2013	Substantially Equivalent	Quidel Corp.
K121633	BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV	Sep 18, 2012	Substantially Equivalent	Becton, Dickinson and Company
K101918	QUICKVUE RSV 10	Sep 24, 2010	Substantially Equivalent	Quidel Corp.
K101514	BD DIRECTIGEN EZ RSV	Jul 09, 2010	Substantially Equivalent	Becton, Dickinson & CO
K091235	RAMP RSV ASSAY	Jul 24, 2009	Substantially Equivalent	Response Biomedical Corp.
K070747	QUICK VUE RSV TEST, MODELS 20193, 20199	Apr 23, 2007	Substantially Equivalent	Quidel Corp.
K041445	IMMUNOCARD STAT! RSV MODEL #750630	Aug 13, 2004	Substantially Equivalent	Meridian Bioscience, Inc.
K032166	BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065	Oct 21, 2003	Substantially Equivalent	Binax, Inc.
K022845	SAS RSV TEST	Jan 29, 2003	Substantially Equivalent	Sa Scientific, Inc.
K023779	RSV OIA	Jan 14, 2003	Substantially Equivalent	Thermo Biostar, Inc.
K022133	BD DIRECTIGEN EZ RSV KIT	Dec 10, 2002	Substantially Equivalent	Becton, Dickinson & CO
K021789	QUICKLAB RSV	Nov 20, 2002	Substantially Equivalent	Integrated Biotechnology Corp.
K021687	BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK	Sep 13, 2002	Substantially Equivalent	Binax, Inc.
K964870	RSV ANTIGEN CONTROL SLIDES	Mar 18, 1997	Substantially Equivalent	Viral Antigens, Inc.
K896097	VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY	Feb 26, 1990	Substantially Equivalent	Vitek Systems, Inc.
K884516	FITC MURINE MONOCLONAL ANTI-RSV IGG	Jan 13, 1989	Substantially Equivalent	Whittaker Bioproducts, Inc.
K882629	DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT	Oct 31, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K882277	ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL	Jun 22, 1988	Substantially Equivalent	Abbott Laboratories
K874127	ABBOTT TESTPACK RSV	May 06, 1988	Substantially Equivalent	Abbott Laboratories
K862743	PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS	Sep 29, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K862429	ABBOTT RSV EIA	Sep 16, 1986	Substantially Equivalent	Abbott Laboratories
K854081	IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST	Jan 03, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K853695	RESPIRATORY SYNCYTIAL VIRUS ID REAGENT	Dec 04, 1985	Substantially Equivalent	Viromed Laboratories, Inc.
K843673	RESPIRATORY SYNCYTIAL VIRUS	Sep 26, 1985	Substantially Equivalent	Institute Virion , Ltd.
K802936	RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &	Dec 31, 1980	Substantially Equivalent	Orion Diagnostica, Inc.
K770808	RESP. SYNCYTIAL-FA LABELLED PRESERUM	May 20, 1977	Substantially Equivalent	Flow Laboratories, Inc.
K770804	RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)	May 20, 1977	Substantially Equivalent	Flow Laboratories, Inc.