The content provided herein may relate to products or workflows that have not been officially CE Marked, authorized by the US FDA or global health agencies, and is subject to change without notice; Refer to current user manual for indications, warning and precautions. All validation data to support the Thermo Fisher Scientific Amplitude Solution has been completed and is currently under review by the Food and Drug Administration. Use of Thermo Fisher Scientific Amplitude Solution is permitted per FDA Policy for Coronavirus Disease-2019 Test during the Public Health Emergency (Revised) released on May 11, 2020.