
Euroimmun Us, LLC
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EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. is an FDA 510(k)-cleared medical device (K060700) 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 September 7, 2006. Regulation: 8.