Elecsys CA-125 II assay

Elecsys CA-125 II assay is an FDA 510(k)-cleared medical device (K143534) manufactured by Roche Professional Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 2015. Regulation: 8.