Product Description
The QuickVue At-Home OTC COVID-19 Test is for FDA Emergency Use Authorization (EUA) Only
For In Vitro Diagnostic (IVD) Use.
â– This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
â– This product has been authorized only for the detection of proteins from SARS-CoV-2,
not for any other viruses or pathogens.
â– 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.
â– For more information on EUAs go here:
https://www.fda.gov/emergency-preparednessand-response/
mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
â– For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
â– For detailed instructions, please visit www.quickvueathome.com
Download User Instructions PDF
How Does the QuickVue At-Home OTC COVID-19 Test Work?
The test uses a gentle self-collected anterior nasal (nares) swab sample to determine a positive or negative COVID-19 result. The swab is swirled in a tube of reagent solution, then removed, before a test strip is inserted. After ten minutes, you can take the strip out of the tube and see your results.
Before you begin the test, it’s important to first read and closely follow the detailed instructions,
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California Proposition 65
These products may expose you to materials and chemicals known to the state of California to cause cancer, birth defects, or other reproductive harm. Click here to download a pdf to hang in your office regarding California Prop 65.
For more information click here or visit www.P65warnings.ca.gov
