Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.
LumiraDx SARS-CoV-2 RNA STAR Complete is available in the US under FDA Emergency Use Authorization. The test has not been FDA cleared or approved. LumiraDx SARS-CoV-2 RNA STAR Complete has been authorized by FDA under an EUA for use by authorized laboratories. The test is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The test is 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 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.