illumigene Pertussis DNA Amplification Assay

illumigene Pertussis DNA Amplification Assay is an FDA 510(k)-cleared medical device (K152285) manufactured by Meridian Bioscience, 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 November 9, 2015. Regulation: 8.