XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY is an FDA 510(k)-cleared medical device (K082118) manufactured by Cepheid. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 2009. Regulation: 8.