ADVIA Centaur CEA Assay

ADVIA Centaur CEA Assay is an FDA 510(k)-cleared medical device (K200215) manufactured by Siemens Healthcare Disgnostics, Inc.. 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 12, 2020. Regulation: 8.