Has my Test Kit expiration date been extended? - QuickVue At-Home

Has my Test Kit expiration date been extended?

The QuickVue COVID-19 Test has been granted FDA EUA authorization to extend expiration dating from 12 months to 16 months. A copy of the letter is available here. Please note the expiration dates on the outer kit box may not reflect the 16-month dating for product that is already distributed.

To verify if the expiration date for a particular lot has been extended:

  • Go to the FDA Webpage »
  • You will require the lot number on your test kit box. If your lot number is not found on this list, it has not been date-extended, and the expiration date listed on the kit box should be used.

  • Symbol for Expiration Date

    Symbol for Expiration Date

    Our QuickVue At-Home OTC COVID-19 Test has received 510(k) clearance by the U.S. FDA under a new name – QuickVue COVID 19-Test.

    The QuickVue COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

    This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first six days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-C0V-2.

    *In the USA, this product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization. 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.

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