ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY

ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY is an FDA 510(k)-cleared medical device (K955449) 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 May 22, 1996. Regulation: 8.