HSVI - IGG ELISA-KIT

HSVI - IGG ELISA-KIT is an FDA 510(k)-cleared medical device (K852782) manufactured by Clinical Sciences, 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 January 20, 1986. Regulation: 8.