VIRGO HSV-2 IGG ELISA

VIRGO HSV-2 IGG ELISA is an FDA 510(k)-cleared medical device (K883281) manufactured by Electro-Nucleonics, 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 9, 1989. Regulation: 8.