This item has been authorized by the FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings to help prevent the spread of infection or illness during the COVID-19 pandemic.
This item is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
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