Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) is an FDA 510(k)-cleared medical device (K200866) 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 May 16, 2020. Regulation: 8.