Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) is an FDA 510(k)-cleared medical device (K172722) 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 December 9, 2017. Regulation: 8.