SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)

SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) is an FDA 510(k)-cleared medical device (K961043) manufactured by Scantibodies Laboratory, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 1996. Regulation: 8.