HSV-2 IGM ELISA TEST--MODIFICATION

HSV-2 IGM ELISA TEST--MODIFICATION is an FDA 510(k)-cleared medical device (K922759) 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.