EUROIMMUN ANTI-NRNP/SM ELISA (IGG)

EUROIMMUN ANTI-NRNP/SM ELISA (IGG) is an FDA 510(k)-cleared medical device (K123261) 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 June 11, 2013. Regulation: 8.