March 2020—The FDA issued an emergency use authorization for the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This test had been limited to use at CDC laboratories; the authorization allows the use of the test at any CDC-qualified lab in the United States.
Read More »Home >> Tag Archives: FDA
FDA issues EUA for first 2019 novel coronavirus diagnostic
Feb. 14, 2020—The FDA issued an emergency use authorization to enable emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
Read More »