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Euroimmun Us, LLC
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EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT is an FDA 510(k)-cleared medical device (K061408) manufactured by Euroimmun Us, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2006. Regulation: 8.