In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. 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.360bblr3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Persons with risk factors for severe disease from respiratory pathogens should consult and follow-up with a healthcare provider.Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative resultwhen you have COVID-19 than a lab-based molecular test.,For complete direction, please reference the Instructions Manual. Kit Contents: 2*Nasal Swabs 2*Test Cards 2*Pre-Filled Tubes. Items necessary to use the test but not provided in the test kits: timer or clock.Use immediately after opening the foil pouch.Avoid contact of the extraction solution in the Test Tube with skin and eyes.For more information about current expiration dates for at-home OTC COVID-19/influenza diagnostic tests, please visit: http://www.fda.gov/covid-testsPatient User instruction:https://www.fda.gov/media/178554/download?attachment.