510(k) Report

Devices descending from K971662

9 later devices reach Elvis HSV ID/Typing Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100336Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences20107—
+1K091753Elvis HSV ID and D3 Typing Test SystemDiagnostic Hybrids, Inc.20090—
+2K142738artus HSV-1/2 QS-RGQ MDx KitQiagen20141—
+2K140198Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc.20142—
+2K111951Isoamp HSV AssayBiohelix Corporation20111—
+3K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc.20180—
+3K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackFocus Diagnostics20150Class I
+3K142156Seegene Anyplex II HSV-1/2 AssaySeegene20150—
+3K140029Amiplivue HSV 1&2 AssayQuidel Corporation20140—