Anti-Borrelia burgdorferi US Westernblot (IgG)

Anti-Borrelia burgdorferi US Westernblot (IgG) is an FDA 510(k)-cleared medical device (K161513) manufactured by Euroimmun US. 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 24, 2016. Regulation: 8.