510(k) Report

Devices descending from K151046

2 later devices reach illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151906ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File…Luminex Corporation201511
+2K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup20180—