QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT

QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT is an FDA 510(k)-cleared medical device (K761058) manufactured by Bio/Data Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1977. Regulation: 8.