NOTE: This Emergency Use Authorization (EUA) is being issued in response to the need for in vitro diagnostic devices to detect antibodies to SARS-CoV-2 during the Coronavirus Disease 2019 (COVID-19) pandemic.
Highly stable and uniform nanoparticles. The quality and performance of a conjugate is critical to successful lateral flow test manufacturing. Our products are produced in a state-of-the-art manufacturing facility that enable rapid turnaround times while ensuring batch to batch consistency and reliability.
This test has not been reviewed by the FDA.