AmplideX Fragile X Dx & Carrier Screen Kit

AmplideX Fragile X Dx & Carrier Screen Kit is an FDA 510(k)-cleared medical device (DEN190023) manufactured by Asuragen, 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 February 20, 2020. Regulation: 8.