ELECSYS RUBELLA IGG IMMUNOASSAY

ELECSYS RUBELLA IGG IMMUNOASSAY is an FDA 510(k)-cleared medical device (K072617) manufactured by Roche Diagnostics Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2008. Regulation: 8.