Emergent SARS-CoV-2 Variants
Discrimination of Omicron from Delta and other variants
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1
CE-marked for in vitro 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.
2
CE-marked for in vitro diagnostic use in the EU.
3
Data on file at Fast Track Diagnostics Luxembourg S.à r.l., a Siemens Healthineers Company. Data is current as of 16 January 2023.
4
88 reactions, when automated on the VERSANT kPCR Molecular System.