ORGEN TEC ANTI-DSDNA ELISA ASSAY

ORGEN TEC ANTI-DSDNA ELISA ASSAY is an FDA 510(k)-cleared medical device (K953671) manufactured by Orgentec. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 1995. Regulation: 8.