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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.
Carestream`s products make a difference every day. Carestream Health is a health imaging and information technology solutions company. We provide medical and healthcare IT solutions and X-ray film and digital X-ray products for the non-destructive testing market worldwide. We also provide product, technical, and service support, including remote equipment and software management services. In addition, we own over 600 patents in digital imaging, healthcare IT, film, and imaging chemistry. We became Carestream in 2007 when Onex Corporation purchased Eastman Kodak`s Health Group. Today, we employ approximately 6,000 people who serve a global customer base in over 150 countries. Carestream is headquartered in Rochester, New York, with locations around the world.
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