ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is an FDA 510(k)-cleared medical device (K163626) manufactured by Luminex 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 May 1, 2017. Regulation: 8.