PAXGENE BLOOD RNA SYSTEM

PAXGENE BLOOD RNA SYSTEM is an FDA 510(k)-cleared medical device (DEN050003) manufactured by Preanalytix GmbH. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 17, 2005. Regulation: 8.