(as of Jun 17,2021 09:22:05 UTC – Details)
* First and only FDA authorized single-use PCR quality molecular test kit for home use SARS-CoV-2 detection in individuals with and without symptoms that provides results in 30 minutes or less. This test is authorized for over-the-counter (OTC) use with self-collected nasal swab samples in individuals with or without COVID-19 symptoms aged 14 and older, and in children aged 2-13 collected by an adult. This test is similar to a PCR test in that it utilizes a molecular amplification technology for the detection of SARS-CoV-2 genetic material. The test does not confirm immunity or detect antibodies. This test is authorized by FDA for Emergency Use during the COVID emergency. *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. * Excluding samples with very low levels of virus (>37.5 Ct), Lucira Community Testing Study 07A-CLI 006 Fall 2020 and Lucira Community Testing Study 07A-CLI 007 Winter 2021 (n=394)
Product Dimensions:7.5 x 3.1 x 2 inches; 5.28 Ounces
Date First Available:April 14, 2021
PCR QUALITY AT-HOME SELF-TEST YOU CAN TRUST: Symptoms or not, Lucira Check It is 98% accurate at detecting SARS-CoV-2 compared to one of the best lab PCR tests.
EASY TO USE, RAPID RESULTS: Includes a shallow nasal swab with easy-to-follow instructions. Results anytime, anywhere in 30 minutes or less.
DETECTS COVID-19 VARIANTS: Lucira surveillance testing shows reactivity to US/CA, UK, South Africa, Japan/Brazil, and India variants.
LUCI PASS, YOUR DIGITAL VERIFIED TEST RESULT: Get a downloadable Lucira COVID-19 test result on your phone for travel, work, school, and events.
FOR AGES 2 TO ADULT: The self-test is authorized for children age 2-13 when administered by an adult, and for self-administration in ages 14 and older.
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