Onclarity™ Self-Collection Kit

Onclarity™ Self-Collection Kit is an FDA 510(k)-cleared medical device (K260184) manufactured by Becton, Dickinson and Company. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2026. Regulation: 8.