COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid-phase immunochromatographic assay for the rapid, qualitative, and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This Rapid Test Kit facilitates patient treatment decisions quickly because of the fast 2 - 10 minutes results. This product is a simple, time-saving procedure that contains all the necessary reagents. COVID-19 Rapid Test Kit is also highly sensitive and specific. This product is FDA / EUA Authorized. FDA / EUA Approval Letter: FDA Letter Product Insert: View or Print Here
Product Non-Refundable, Non-Returnable
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid-phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with an alternative testing method(s) and clinical findings.
This test has not been FDA cleared or approved. 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 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.
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