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Euroimmun US
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EUROIMMUN ANTI-ENA POOL ELISA (IGG) is an FDA 510(k)-cleared medical device (K112996) manufactured by Euroimmun US. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 2013. Regulation: 8.