
American Diagnostica, Inc.
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DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA is an FDA 510(k)-cleared medical device (K935254) manufactured by American Diagnostica, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 18, 1994. Regulation: 8.