510(k) Report

Devices descending from DEN130032

1 later device reach Xpert MTB/Rif Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143302Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s…Cepheid201501