COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA is an FDA 510(k)-cleared medical device (K912940) manufactured by Diagnostic Products Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 23, 1991. Regulation: 8.