binx io CT/NG Assay and binx io CT/NG System

binx io CT/NG Assay and binx io CT/NG System is an FDA 510(k)-cleared medical device (K200533) manufactured by Binx Health, 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 April 26, 2020. Regulation: 8.