510(k) Report

Devices descending from K012351

21 later devices reach Bdprobetec ET CT/GC Amplified Dna Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121710Xpert CT/NGCepheid201273
+1K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Abbott Molecular, Inc.2010111
+1K080739Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc.20080—
+2K200748Visby Medical Sexual HealthVisby Medical20212—
+2K173840Xpert CT/NGCepheid20181—
+2K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid20154—
+2K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc.2012102
+3K220407Visby Medical Sexual Health TestVisby Medical20231—
+3K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…Cepheid20190—
+3K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.20177—
+3K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+3K140887Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20140—
+3K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20139—
+4K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—
+4K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20186—
+5K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20250—
+5K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20250—
+5K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20213—
+6K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc.20260—
+6K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20260—
+6K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20260—