510(k) Report

Devices descending from K191957

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260021cobas® BV/CVRoche Molecular Systems, Inc.20260—
+1K243725BD Vaginal PanelBecton, Dickinson and Company20240—
+1K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20222—
+1K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences)20212—
+2K223653BD Vaginal PanelBecton, Dickinson and Company20231—
+2K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20221—
+3K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid20230—