IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT is an FDA 510(k)-cleared medical device (K980855) manufactured by Dpc Cirrus. 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 20, 1998. Regulation: 8.