ORGENTEC RHEUMATOID FACTOR EIA

ORGENTEC RHEUMATOID FACTOR EIA is an FDA 510(k)-cleared medical device (K100499) manufactured by Orgentec Diagnostika GmbH. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2010. Regulation: 8.