EUROIMMUN ANTI-M2-3E ELISA (IGG)

EUROIMMUN ANTI-M2-3E ELISA (IGG) is an FDA 510(k)-cleared medical device (K092736) 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 September 1, 2010. Regulation: 8.