binx health io CT/NG Assay

binx health io CT/NG Assay is an FDA 510(k)-cleared medical device (K191352) 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 August 7, 2019. Regulation: 8.