ANTINUCLEAR ANTIBODY SCREEN FLOURESC

ANTINUCLEAR ANTIBODY SCREEN FLOURESC is an FDA 510(k)-cleared medical device (K821576) manufactured by Immuno-Products Industries. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 1982. Regulation: 8.