HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is an FDA 510(k)-cleared medical device (K180559) manufactured by Elitechgroup. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2018. Regulation: 8.