ZEUS Rapid SARS-CoV-2 IgM/IgG Antibody Test System Validated, Ready for Distribution
On April 28th, 2020 ZEUS Scientific officially notified the U.S. FDA that it has validated the ZEUS Rapid SARS-CoV-2 IgM/IgG Test System and intends to begin distributing this product to laboratories. ZEUS has met the requirements defined in the guidance documents provided by the FDA applicable to serological assays designed to detect antibodies to the SARS-CoV-2 virus (novel 2019 coronavirus). You can review the FDA Guidance document detailing what is required to market serological antibody tests on page 9 (IV Policy D).
While ZEUS officially filed an Authorization for Emergency Use of the rapid device on April 22nd, 2020 by meeting the requirements of the FDA to market the test now, we can work together with laboratories to enable rapid detection of cases and contacts, infection control and community mitigation efforts. ZEUS continues to pursue this EUA to reinforce its long standing commitment to product quality, with its extensive history of regulatory approvals with the FDA.
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