ORGENTEC ANTI-PR3 (C-ANCA) ELISA

ORGENTEC ANTI-PR3 (C-ANCA) ELISA is an FDA 510(k)-cleared medical device (K974702) manufactured by American Laboratory Products Co., Ltd.. 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 16, 1998. Regulation: 8.