Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit is an FDA 510(k)-cleared medical device (K200023) 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 April 5, 2020. Regulation: 8.