• 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 and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• 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 the 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.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• This product is intended for professional use and not for home use
• Not for the screening of donated blood
This test has not been approved by the FDA