ALL COVID TESTS ARE NON-RETURNABLE.
COVID-19 IgG/IgM Rapid Test Cassette – FDA Emergency Use Authorized
The Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
COVID-19 (Coronavirus Disease) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December of 2019.
The COVID-19 rapid test is manufactured by Hangzhou Biotest Biotech, Co., Ltd. and distributed by Premier Biotech.
EUA Authorized Serology Test Performance – Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette
Developer: Hangzhou Biotest Biotech
Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike
Statements And Conditions:
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has not been FDA cleared or approved;
This test has been authorized only for the presence of lgM 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)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
Not for screening of donated blood
