EUROIMMUN Anti-West Nile Virus ELISA (IgM)

EUROIMMUN Anti-West Nile Virus ELISA (IgM) is an FDA 510(k)-cleared medical device (K153308) manufactured by Euroimmun Us, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 2016. Regulation: 8.