510(k) Report

Devices descending from K100336

7 later devices reach Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142738artus HSV-1/2 QS-RGQ MDx KitQiagen20141—
+1K140198Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc.20142—
+1K111951Isoamp HSV AssayBiohelix Corporation20111—
+2K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc.20180—
+2K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics20150Class I
+2K142156Seegene Anyplex II HSV-1/2 AssaySeegene20150—
+2K140029Amiplivue HSV 1&2 AssayQuidel Corporation20140—