Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit is an FDA 510(k)-cleared medical device (K203296) manufactured by Gold Standard Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 2021. Regulation: 8.