quest diagnostic oakland make appointment

This means that while Quest Diagnostics has validated the test and has the data to believe the test and the collection kit are accurate, this test has not been FDA cleared or approved this test has been authorized by FDA under an EUA for use by authorized laboratories this test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens and, this test 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 Act, 21 U.S.C. This test has been authorized by the FDA under an Emergency Use Authorization (EUA). § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.Ībout the FDA Emergency Use Authorization (EUA) Status The molecular tests are 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 Act, 21 U.S.C.The molecular tests have been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens and,.The molecular tests have been authorized by FDA under an EUA for use by authorized laboratories.The Quest Diagnostics molecular test and other authorized molecular tests (together the “molecular tests”) have not been FDA cleared or approved.

Quest diagnostic oakland make appointment