Solana Bordetella Complete Assay

Solana Bordetella Complete Assay is an FDA 510(k)-cleared medical device (K181029) 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 July 14, 2018. Regulation: 8.