RUBELLA IGG ANTIBODY ELISA TEST SYS

RUBELLA IGG ANTIBODY ELISA TEST SYS is an FDA 510(k)-cleared medical device (K841200) manufactured by Ortho Diagnostic Systems, 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 May 20, 1984. Regulation: 8.