HSV-1 ELISA IGG, MODEL EL0910G

HSV-1 ELISA IGG, MODEL EL0910G is an FDA 510(k)-cleared medical device (K993754) 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 February 8, 2000. Regulation: 8.