AmpliVue Bordetella Assay

AmpliVue Bordetella Assay is an FDA 510(k)-cleared medical device (K143206) manufactured by Quidel Corporation. 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 9, 2014. Regulation: 8.