EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)

EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) is an FDA 510(k)-cleared medical device (K140224) 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 December 8, 2014. Regulation: 8.