COVID-19 IgG/IgMRapid Test Cassette
FDA Emergency Use Authorized. By Premier Biotech
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the COVID-19 IgG and IgM rapid test manufactured by Hangzhou Biotest Biotech, Co., Ltd. (“Biotest”) and distributed by Premier Biotech, used for the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in whole blood, serum, or plasma. The product includes a complete testing kit that produces results in 10 minutes.
- Premier Biotech plans to ramp up distribution of the product in all 50 U.S. states, enhancing U.S. COVID-19 antibody testing infrastructure critical to effective response efforts.
- Kit Contents include test cassette, buffer solution, disposable capillary, and package insert.
- FDA Authorization Letter/Additional Documents: https://premierbiotech.com/innovation/covid-19/
