Celltrion Diatrust At-Home COVID-19 Test
lets you get rapid results, in the privacy of your own home. This test is authorized for non-prescription home use with self-collected and adult-collected direct mid-turbinate swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; 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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