510(k) Report

Devices descending from K121539

2 later devices reach Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20220—
+1K181156Panther Fusion GBS AssayDiagenode201802