510(k) Report

Devices descending from K212213

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20221—
+2K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid20230—