
Diamedix Corp.
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DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM is an FDA 510(k)-cleared medical device (K013628) 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 December 20, 2001. Regulation: 8.