HSV-2 IGM ELISA TEST

HSV-2 IGM ELISA TEST is an FDA 510(k)-cleared medical device (K910953) manufactured by Gull Laboratories, 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 27, 1991. Regulation: 8.