Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is an FDA 510(k)-cleared medical device (K173798) manufactured by Diasorin Molecular, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 2018. Regulation: 8.