BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST

BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST is an FDA 510(k)-cleared medical device (K925355) manufactured by Princeton Biomedix. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 1994. Regulation: 8.