ANTINUCLEAR ANTIBODY IMMUNOLOGICAL

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL is an FDA 510(k)-cleared medical device (K833984) manufactured by Intl. Diagnostic Technology. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 1984. Regulation: 8.