![]() ![]() Additional studies need to be conducted for this test and others like it to be FDA cleared or approved. § 360BBB-3(B)(1), unless the authorization is terminated or revoked sooner. 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. For special procedures, by phone: 70 For PET scans, by phone: 70 For online scheduling please note SDMI must first receive a referral from your doctor, you will then received a text or email to schedule online. This test has been authorized by the FDA under an Emergency Use Authorization (EUA). How do I schedule an appointment For general imaging, by phone: 70 (option 1). Quest Diagnostics - Book Online - Lab Testing in Henderson, NV 89052 Solv. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.Ībout the FDA Emergency Use Authorization (EUA) Status
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