Lucira is the first and only FDA EUA authorized single-use molecular test available over-the-counter. Get results at home in 30 minutes or less.
For FDA Emergency Use Authorization (EUA) Only. For Over-The-Counter Use. For In Vitro Diagnostic (IVD) Use.
Fast, accurate, at-home results mean you can now test whenever you need to. And Lucira Check It is suitable for the whole family, with adults administering the test for children ages 2-13.
Lucira is clinically proven to have PCR quality molecular accuracy. In multiple clinical studies that included individuals with and without COVID-19 symptoms, Lucira achieved 98% accuracy when compared to one of the best FDA authorized known high sensitivity PCR tests1.
We created the LUCI PASS™ to make it easy for you to receive a free, verified Lucira test result. After taking our test, you simply text to access our secure LUCI portal, and then follow a few steps to submit your results.
FDA News Release – November 17, 2020
Lucira News Release – February 12, 2021
Seeking Alpha – February 21, 2021
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.