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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.
Exponent Corp is a Branchburg, NJ-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Dale Medical Products is a Plainville, MA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
CMA MICRODIALYSIS is a North Chelmsford, MA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
FUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment. Fujifilm`s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. The Synapse® Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record. REiLI®, Fujifilm`s artificial intelligence initiative, combines Fujifilm`s rich image -processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products.