
Eurodiagnostica
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IMMUNOSCAN RA ANTI-CCP TEST SYSTEM is an FDA 510(k)-cleared medical device (K052133) manufactured by Eurodiagnostica. 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 11, 2005. Regulation: 8.