FTD SARS-CoV-2 Assay

For the specific detection of the coronavirus causing COVID-19 using RT-PCR

Product availability varies by country and is subject to local regulatory requirements.

*Data on file at Fast Track Diagnostics, A Siemens Healthineers Company, Luxembourg 

CE-IVD labelled for diagnostic use in the EU. This test has not been FDA cleared or approved. This test has been authorized by 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. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.