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Corgenix, Inc.
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REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 is an FDA 510(k)-cleared medical device (K031208) manufactured by Corgenix, 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 July 6, 2003. Regulation: 8.