home covid test in Portugal

Product Description

home covid test in Portugal

Specimen type: Nasal (NS) swab specimen

Turnaround time: The test is intended to be read at 10 minutes. If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate (false negative, false positive, or invalid) and the test should be repeated.

CLIA complexity: authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) home covid test in Portugal swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. FDA status: EUA granted

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

This product has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens; and,

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. home covid test in Portugal  360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.