
Diamedix Corp.
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DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM is an FDA 510(k)-cleared medical device (K994424) manufactured by Diamedix Corp.. 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 17, 2000. Regulation: 8.