ID NOW™ is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide.
The ID NOW™ COVID-19 assay is now available for use on the ID NOW platform under U.S. Food and Drug Administration Emergency Use Authorization (EUA). The ID NOW™ COVID-19 rapid test delivers high-quality molecular positive results in as little as 5 minutes, targeting the coronavirus (COVID-19) RdRp Gene.
Timely results enable healthcare professionals to make appropriate and more efficient treatment and infection control decisions. EUA supports flexible near patient testing environments.
Only available in the US.
ID NOW™ COVID-19 and ID NOW COVID-19 2.0 have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and are 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
1. Please see ID NOW Instrument User manual for additional operating environment requirements.
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