FDA Grants Hardy Diagnostics Emergency Use Authorization (EUA) for a Rapid Antibody Test Kit for COVID-19
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...
2020-04-28 11:44 PM EDT
Hardy Diagnostics Announces Release of a Rapid Test for Patients Suspected of COVID-19 Infection
Santa Maria, California--(Newsfile Corp. - March 25, 2020) - Hardy Diagnostics, a medical device manufacturer based in Santa Maria, California, announced it has begun accepting orders for a new in vitro diagnostic medical device: Anti-SARS-CoV-2 Rapid Test (Cat. No. RTA0203). This immunoassay is intended specifically for determining the possibility of a COVID-19 infection and was developed by Autobio Diagnostics Co., Ltd (
2020-03-25 1:19 AM EDT