EUROIMMUN Anti-BP230-CF ELISA (IgG)

EUROIMMUN Anti-BP230-CF ELISA (IgG) is an FDA 510(k)-cleared medical device (K193115) 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 16, 2020. Regulation: 8.