artus HSV-1/2 QS-RGQ MDx Kit

artus HSV-1/2 QS-RGQ MDx Kit is an FDA 510(k)-cleared medical device (K142738) manufactured by Qiagen. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2014. Regulation: 8.