ELECSYS HSV-2 IGG IMMUNOASSAY

ELECSYS HSV-2 IGG IMMUNOASSAY is an FDA 510(k)-cleared medical device (K121895) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 23, 2012. Regulation: 8.