iHealth Covid-19 Antigen Rapid Test, 2 count
Description
iHealth Covid-19 Antigen Rapid Test, 2 count The iHealth Covid-19 Antigen Rapid Test is intended for the qualitative detection of Sars-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples. • If you have symptoms of Covid-19, you can use a single test. • If you do not have symptoms of Covid-19, you will need at least two tests per person. You may need to purchase additional tests to perform serial (repeat) testing. • This test is more likely to give you a false negative result when you have Covid-19 than a lab-based molecular test. This test does not determine if you had Covid-19 in the past or if you have immunity. • 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, 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.Description
iHealth Covid-19 Antigen Rapid Test, 2 count The iHealth Covid-19 Antigen Rapid Test is intended for the qualitative detection of Sars-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples. • If you have symptoms of Covid-19, you can use a single test. • If you do not have symptoms of Covid-19, you will need at least two tests per person. You may need to purchase additional tests to perform serial (repeat) testing. • This test is more likely to give you a false negative result when you have Covid-19 than a lab-based molecular test. This test does not determine if you had Covid-19 in the past or if you have immunity. • 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, 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.Legal
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