For instructions on how to collect and package samples, please refer to the instructions for use linked at the bottom of this article.
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Disclaimer
These COVID-19 tests have not been FDA cleared or approved; but have been authorized by FDA under an Emergency Use Authorization (“EUA”). The COVID-19 tests provided have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The COVID-19 tests provided are only authorized for the duration of the declaration that circumstances exist justifying the authorization or emergency use of in vitro diagnostics 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.