Panther Fusion Paraflu Assay

Panther Fusion Paraflu Assay is an FDA 510(k)-cleared medical device (K172282) manufactured by Hologic, Inc.. 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 22, 2017. Regulation: 8.