Aptima Neisseria gonorrhoeae Assay

Aptima Neisseria gonorrhoeae Assay is an FDA 510(k)-cleared medical device (K231329) 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 January 25, 2024. Regulation: 8.