510(k) Report

Devices descending from K151565

4 later devices reach Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200748Visby Medical Sexual HealthVisby Medical20212—
+1K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+2K220407Visby Medical Sexual Health TestVisby Medical20231—
+3K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—