PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY is an FDA 510(k)-cleared medical device (K141771) manufactured by Nanostring 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 November 6, 2014. Regulation: 8.