TINA-QUANT CERULOPLASMIN

TINA-QUANT CERULOPLASMIN is an FDA 510(k)-cleared medical device (K091741) manufactured by Roche 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 March 17, 2010. Regulation: 8.