BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT is an FDA 510(k)-cleared medical device (K120959) manufactured by Bio-Rad Laboratories. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 2012. Regulation: 8.