MODIFICATION RUBELLA IGM EIA TEST KIT

MODIFICATION RUBELLA IGM EIA TEST KIT is an FDA 510(k)-cleared medical device (K873780) manufactured by Labsystems, 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 October 14, 1987. Regulation: 8.