Beschreibung
PHOENIXDX® SARS-COV-2 MULTIPLEX IVD detects the presence of 2 different and highly specific gene sequences of corona viruses and one sequence specific for human RNA serving as a human extraction control (HEC). Additionally, a non-infectious target positive control (TPC) is included. The positive control is used to confirm functionality of the assays and overall PCR performance, the human extraction control is to evaluate the quality of the RNA isolation independently from the SARS-CoV-2 assays in a different detection channel.
Download the FDA EUA here
Download MSDS here
Download IFU here