EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern is an FDA 510(k)-cleared medical device (K172252) 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 April 19, 2018. Regulation: 8.