INCSTAR RUBELLA IGG ELISA ASSAY

INCSTAR RUBELLA IGG ELISA ASSAY is an FDA 510(k)-cleared medical device (K960367) manufactured by Incstar 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 October 23, 1996. Regulation: 8.