Aptima SARS-CoV-2 Assay

Aptima SARS-CoV-2 Assay is an FDA 510(k)-cleared medical device (K243396) 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 February 12, 2025. Regulation: 8.