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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
K843659institute virionINFLUENZA A2 VIRUSSeptember 26, 1985
K843660institute virionIN FLUENZA B VIRUSSeptember 26, 1985
K802931orion diagnosticaINFLUENZA A & B S-ANTIGEN & CONTROLSJanuary 12, 1981