RUBELLA VIRUS ANTIGENS & CONTROLS

RUBELLA VIRUS ANTIGENS & CONTROLS is an FDA 510(k)-cleared medical device (K802937) manufactured by Orion Diagnostica, Inc.. 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 30, 1980. Regulation: 8.