HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM

HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K983656) manufactured by Zeus Scientific, 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 March 17, 1999. Regulation: 8.