IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES

IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES is an FDA 510(k)-cleared medical device (K962360) 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 September 29, 1996. Regulation: 8.