HSV-2 ELISA IGG, MODEL EL0920G

HSV-2 ELISA IGG, MODEL EL0920G is an FDA 510(k)-cleared medical device (K993724) manufactured by Mrl Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 2000. Regulation: 8.