HSV-1 IGM ELISA TEST -- MODIFICATION

HSV-1 IGM ELISA TEST -- MODIFICATION is an FDA 510(k)-cleared medical device (K922758) 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 October 4, 1992. Regulation: 8.