NeuMoDx CT/NG Assay 2.0

NeuMoDx CT/NG Assay 2.0 is an FDA 510(k)-cleared medical device (K230267) manufactured by Neumodx Molecular, 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 December 21, 2023. Regulation: 8.