LumiraDx SARS-CoV-2 RNA STAR and LumiraDx SARS-CoV-2 RNA STAR Complete are available in the US under FDA Emergency Use Authorization. These tests have not been FDA cleared or approved. LumiraDx SARS-CoV-2 RNA STAR and LumiraDx SARS-CoV-2 RNA STAR Complete have been authorized by FDA under an EUA for use by authorized laboratories. These tests are only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The tests are only authorized in the United States 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Users should refer to the LumiraDx SARS-CoV-2 RNA STAR and the LumiraDx SARS-CoV-2 RNA STAR Complete Instructions for Use posted on the FDA website for all IVD products used under Emergency Use Authorization, http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm