Features & Benefits:

• • 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 presence of IgM 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner