360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.: This PCR (polymerase chain reaction) test is the same test used by physicians across the U.S. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. This product has only been authorized by FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. This means that this product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. Pixel by Labcorp Home Collection KitPixel by Labcorp offers this product with an FDA Emergency Use Authorization (EUA). The test is available at CVS.com and in 5,600 CVS Pharmacy locations as the week of April 19, with additional locations to follow. The box contains two tests which should be administered twice over three days with at least 36 hours between tests. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.: Reliable fully at-home test for surveillance and frequent use delivers results in 15 minutes. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. They have been authorized by the FDA under an emergency use authorization. It will be in select locations in RI and MA the week of April 19, with increasing availability on CVS.com and in most CVS Pharmacy locations by the end of May.Ībbott BinaxNOW COVID-19 Antigen Self-Test $23.99The BinaxNOW COVID-19 Antigen Self Tests have not been FDA cleared or approved. CVS Pharmacy is the first retailer to carry the Ellume Home Test Kit. The test delivers results in 15 minutes through a free app downloaded to a smartphone, without the need for a second test. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.: The first rapid, fully at-home test to receive Emergency Use Authorization by the FDA for at-home use without a prescription.

This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. The three testing options now available at CVS include:Įllume COVID-19 Home Test Kit $38.99The Ellume COVID-19 Home Test has not been FDA cleared or approved but has been authorized by the FDA under an emergency use authorization.

'CVS Health has been a leader in providing accessible testing in communities nationwide, and we continue to bring new solutions to market to ensure that consumers have a variety of COVID-19 testing options available to them.' Making OTC COVID-19 tests available to our customers helps remove barriers by providing convenient options for testing,' said George Coleman, Senior Vice President and Chief Merchant, CVS Pharmacy.

'Access to testing continues to be an important part of the nation's pandemic response. These options provide customers with access to convenient testing that can be conducted at home and complement CVS Health's commitment to providing consumers with access to comprehensive COVID-19 testing services. All three tests have received FDA Emergency Use Authorization (EUA), do not require a prescription, and are intended for use by individuals with or without symptoms. The tests include the Ellume COVID-19 Home Test, the Abbott BinaxNOW COVID-19 Antigen Self Test and the Pixel by Labcorp PCR Test Home Collection Kit. CVS Pharmacy, the retail division of CVS Health (NYSE: CVS), today announced the availability of three over-the-counter COVID-19 testing options in stores and online. Retailer expands access to convenient, at-home testing options with new-to-market, home tests available in stores and online

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