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empowerDX 4-in-1 Family at-Home COVID-19 Nasal PCR Test, FDA Authorized (Home-Collected)

Product ID : 46186010


Galleon Product ID 46186010
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15,542

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About EmpowerDX 4-in-1 Family At-Home COVID-19 Nasal PCR

At-Home COVID-19 Test? Nasal PCR tests are a fast, affordable, and painless way to get tested for the COVID-19 virus right from your own home. This clinical diagnostic test is FDA Emergency Use Authorized (EUA). This test is not for severe symptoms. HOW IT WORKS Simply order a test, collect a pain-free sample, and ship it back to the lab for results in just 48 hours (weekdays only). The price includes tax and shipping to and from the lab – so there won’t be any surprise costs to you. Or just pay with insurance. The Nasal PCR Test is approved for ages 3+. AIRLINE APPROVED COVID-19 TEST If you need a COVID-19 test before your flight, this molecular nasal PCR test is airline-approved. CLIA CERTIFIED empowerDX laboratories are CLIA certified. This means the FDA and CDC have ensured their tests, methods and practices meet rigorous standards. As of December 2020, our lab’s SARS-CoV-2 assay offers the best sensitivity of the 118 laboratories that have submitted results to FDA’s SARS-CoV-2 Reference Panel, with a limit of detection (LoD) of 180 NAAT Detectable Units/mL1. This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA; This product 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; and The emergency use of this product only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices 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.