KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT is an FDA 510(k)-cleared medical device (K080159) manufactured by Kronus Market Development Associates, 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 May 21, 2008. Regulation: 8.