Product Manual

The QuickVue At-Home OTC COVID-19 Test is

for FDA Emergency Use Authorization (EUA) Only

For

In Vitro

Diagnostic (IVD) Use.

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This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.

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This product has been authorized only for the detection of proteins from SARS-CoV-2,

not for any other viruses or pathogens.

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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 IVDs 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.

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For more information on EUAs go here:

https://www.fda.gov/emergency-preparednessand-response/

mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

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For detailed instructions, please visit