IMDX HSV-1/2 FOR ABBOTT M2000

IMDX HSV-1/2 FOR ABBOTT M2000 is an FDA 510(k)-cleared medical device (K140198) manufactured by Intelligent Medical Devices, 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 12, 2014. Regulation: 8.