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Lucira Health has developed an at home COVID-19 test kit that delivers PCR quality molecular accuracy in the palm of your hand in 30 minutes or less. Our technology is transforming how we reduce the spread of infectious diseases by bringing accurate, easy-to-use self-testing into the home. This home test kit has not been FDA cleared or approved. This home test kit has been authorized by FDA under EUA. This home test kit has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs 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 declaration is terminated or revoked sooner.
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