Sofia 2 Lyme FIA, Sofia Lyme Control Set

Sofia 2 Lyme FIA, Sofia Lyme Control Set is an FDA 510(k)-cleared medical device (K173496) 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 August 29, 2018. Regulation: 8.