Solana GAS Assay, Solana instrument

Solana GAS Assay, Solana instrument is an FDA 510(k)-cleared medical device (K150868) 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 June 22, 2015. Regulation: 8.