
Rhigene, Inc.
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RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 is an FDA 510(k)-cleared medical device (K031308) manufactured by Rhigene, 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 September 25, 2003. Regulation: 8.