Lyra RSV+hMPV Assay

Lyra RSV+hMPV Assay is an FDA 510(k)-cleared medical device (K230349) 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 March 9, 2023. Regulation: 8.