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GNX — Antigens, Cf (Including Cf Control), Influenza Virus A, B, C Class I

FDA Device Classification

Classification Details

Product Code
GNX
Device Class
Class I
Regulation Number
866.3330
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K133411alere scarborough, inc d/b/a binaxALERE BINAXNOW INFLUENZA A & B CARDDecember 5, 2013
K132352sa scientificSAS FLUALERT A & B, SAS INFLUENZA A TESTAugust 22, 2013
K131804remelREMEL XPECT FLU A&BJuly 12, 2013
K131606quidelSOFIA INFLUENZA A+B FIAJuly 5, 2013
K131599quidel corporationQUICK VUE INFLUENZAJuly 5, 2013
K131619quidelQUICKVUE INFLUENZA A+BJune 28, 2013
K123182sekisui diagnosticsOSOM INFLUENZA A&B TEST MODEL 190November 5, 2012
K971494zymetxVIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESSeptember 10, 1997
K924006baxter healthcareBARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAYDecember 29, 1992
K901493whittaker bioproductsFITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE BJune 27, 1990
K893579whittaker bioproductsFITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE AJanuary 16, 1990
K884191baxter diagnosticsINFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTIONNovember 22, 1988
K872958boots-celltech diagnosticsIMAGEN INFLUENZA VIRUS A AND B TESTMIFebruary 24, 1988
K871231microscan div. baxter healthcareANTIBODY ASSAY FOR DETECTION OF INFLUENZA BJune 26, 1987
K871233microscan div. baxter healthcareANTIBODY ASSAY FOR DETECTION OF INFLUENZA AJune 26, 1987
K843660institute virionIN FLUENZA B VIRUSSeptember 26, 1985
K843659institute virionINFLUENZA A2 VIRUSSeptember 26, 1985
K802931orion diagnosticaINFLUENZA A & B S-ANTIGEN & CONTROLSJanuary 12, 1981