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Immuno Concepts, Inc.
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IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G is an FDA 510(k)-cleared medical device (K013432) manufactured by Immuno Concepts, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2001. Regulation: 8.