510(k) Report

Devices descending from K221160

1 later device reach Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid20230—