IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES

IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES is an FDA 510(k)-cleared medical device (K970198) manufactured by Scimedx 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 19, 1997. Regulation: 8.