Aptima HCV Quant Dx Assay

Aptima HCV Quant Dx Assay is an FDA 510(k)-cleared medical device (K233352) 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 July 23, 2024. Regulation: 8.