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Euroimmun Us, Inc.
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EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) is an FDA 510(k)-cleared medical device (K082130) manufactured by Euroimmun Us, 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 April 6, 2009. Regulation: 8.