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This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. This test has not been FDA cleared or approved. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This 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. (Gettestednow.com provides tests from Infinity BiologiX (formerly RUCDR), who have received an EUA from the FDA for home saliva collection. Gettestednow.com works closely with Infinity BiologiX to ensure their distribution of these authorized tests is fully compliant with the parameters of their authorization, and with any regulatory updates or changes.)

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