CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT

CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT is an FDA 510(k)-cleared medical device (K033105) manufactured by Trinity Biotech USA. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2004. Regulation: 8.