AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA is an FDA 510(k)-cleared medical device (K993085) manufactured by Cogent Diagnotics , 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 January 31, 2000. Regulation: 8.