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. ![]() Passwords are case sensitive and cannot be the same as the Username. Passwords must be at least 8 characters long and contain at least one alphabetic and one numeric or special character. 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. In-home sample collection may be available in your area for purchase through Quest Mobile for 55. Username must be at least 8 characters long and is not case sensitive. This test has been authorized by the FDA under an Emergency Use Authorization (EUA). We also collaborate with many international diagnostic laboratories, hospitals and clinics to help improve human health. Our products and services are used by customers in over 130 countries. Find a Quest Diagnostics location near you, answer questions, and book an appointment online. and operations in India, Ireland, and Mexico. Learn how to schedule an appointment for lab testing after making a purchase from. Quest Diagnostics has headquarters in the U.S. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.Ībout the FDA Emergency Use Authorization (EUA) Status Lab testing, laboratory and office locations around the world. 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.
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