FDA Grants Hardy Diagnostics Emergency Use Authorization (EUA) for a Rapid Antibody Test Kit for COVID-19

Strategic partnership with Autobio Diagnostics Co., Ltd enables Hardy Diagnostics to become exclusive U.S. supplier of a new rapid, one-step lateral flow assay that detects IgM and IgG antibodies to the SARS-CoV-2 virus

Santa Maria, California–(Newsfile Corp. – April 28, 2020) –  Hardy Diagnostics, a medical device manufacturer based in Santa Maria, California, announced FDA EUA approval on April 24 for a new in vitro diagnostic medical device: Anti-SARS-CoV-2 Rapid Test (Cat. No. RTA0203).

This immunoassay is intended for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma or serum. This test was developed by Autobio Diagnostics Co., Ltd (603658, Shanghai), a publicly traded major microbiology medical device manufacturer based in Zhengzhou, China. Through this partnership, Hardy Diagnostics and Autobio have begun to open supply chains to exclusively deliver this rapid test to the United States. This rapid market deployment of a new in vitro diagnostic medical device was made possible through the FDA Emergency Use Authorization (EUA) program. This program is used in times of crisis, such as the current COVID-19 pandemic.