SOPHEIA MP IGM RHEUMATOID FACTOR EIA

SOPHEIA MP IGM RHEUMATOID FACTOR EIA is an FDA 510(k)-cleared medical device (K840049) 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 February 9, 1984. Regulation: 8.