Real Time Fluorescent RT-PCR kit for detecting 2019 nCoV (SARS-CoV-2) from BGI
This test has been authorized by the FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARs-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
This test has not been FDA cleared or approved;
For in vitro diagnostic use only.