cobas HSV 1 and 2 Test

cobas HSV 1 and 2 Test is an FDA 510(k)-cleared medical device (K150617) manufactured by Roche Molecular Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2015. Regulation: 8.