In the fight against COVID-19, having multiple tests for different settings and stages of a person’s infection is key, from high-volume laboratory capabilities to fast solutions that give results on the spot, from tests that detect the active virus to tests that detect antibodies in people who were previously infected. The portable, rapid molecular ID NOW COVID-19 test has emerged as a critical part of this arsenal, allowing fast diagnosis — with results in 13 minutes or less — in a variety of locations such as physicians’ offices, urgent care clinics and other point-of-care locations. Find out more about this innovative technology and its impact here.
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The ID NOW COVID-19 and ID NOW COVID-19 2.0 products have not been FDA cleared or approved. They have been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories and patient care settings. The tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and 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.
