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GQG — Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus Class I

FDA Device Classification

Classification Details

Product Code
GQG
Device Class
Class I
Regulation Number
866.3480
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253318hangzhou clongene biotech coClungene RSV Antigen Rapid TestJanuary 30, 2026
K240280nano-ditech corporationNano-Check™ RSV TestJuly 30, 2024
K162911quidel corporationSofia RSV FIA on Sofia 2 analyzerFebruary 22, 2017
K133140becton, dickinson andBD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVNovember 15, 2013
K132456becton, dickinson andBD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVNovember 7, 2013
K130398quidelSOFIA(R) RSV FIAAugust 13, 2013
K121633becton, dickinson andBD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSVSeptember 18, 2012
K101918quidelQUICKVUE RSV 10September 24, 2010
K101514becton, dickinson andBD DIRECTIGEN EZ RSVJuly 9, 2010
K091235response biomedicalRAMP RSV ASSAYJuly 24, 2009
K070747quidelQUICK VUE RSV TEST, MODELS 20193, 20199April 23, 2007
K041445meridian bioscienceIMMUNOCARD STAT! RSV MODEL #750630August 13, 2004
K032166binaxBINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PAOctober 21, 2003
K022845sa scientificSAS RSV TESTJanuary 29, 2003
K023779thermo biostarRSV OIAJanuary 14, 2003
K022133becton, dickinson andBD DIRECTIGEN EZ RSV KITDecember 10, 2002
K021789integrated biotechnologyQUICKLAB RSVNovember 20, 2002
K021687binaxBINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PSeptember 13, 2002
K964870viral antigensRSV ANTIGEN CONTROL SLIDESMarch 18, 1997
K896097vitek systemsVIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAYFebruary 26, 1990