510(k) Report

Devices descending from DEN160001

11 later devices reach BD MAX Vaginal Panel, BD MAX Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243725BD Vaginal PanelBecton, Dickinson and Company20240—
+1K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences)20212—
+1K191957BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics)20197—
+1K190452Aptima BV AssayHologic, Inc.20191—
+1K190472Aptima CV/TV AssayHologic, Inc.20191—
+2K260021cobas® BV/CVRoche Molecular Systems, Inc.20260—
+2K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.20240—
+2K223653BD Vaginal PanelBecton, Dickinson and Company20231—
+2K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20222—
+3K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20221—
+4K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid20230—