Aptima BV Assay; Aptima CV/TV Assay

Aptima BV Assay; Aptima CV/TV Assay is an FDA 510(k)-cleared medical device (K243345) 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 November 24, 2024. Regulation: 8.