Sofia Lyme FIA, Sofia Lyme Control Set

Sofia Lyme FIA, Sofia Lyme Control Set is an FDA 510(k)-cleared medical device (K163713) manufactured by Quidel Corporation. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 2017. Regulation: 8.