GenetiSure Dx Postnatal Assay

GenetiSure Dx Postnatal Assay is an FDA 510(k)-cleared medical device (K163367) manufactured by Agilent Technologies, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2017. Regulation: 8.