The Everlywell COVID-19 Test Home Collection Kit and any other test kit mentioned on this page have not been FDA cleared or approved.
The Everlywell COVID-19 Test Home Collection Kit has been authorized by the FDA under an EUA.
The Everlywell COVID-19 Test Home Collection Kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Everlywell COVID-19 Test Home Collection Kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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