ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV is an FDA 510(k)-cleared medical device (K120625) manufactured by Roche 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 July 24, 2012. Regulation: 8.