Confirm BioSciences secures EUA for COVID-19 antibody test

2020 05 07 22 45 7209 Lab Tech Coronavirus Sample 400

Confirm BioSciences has secured an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 immunoglobulin G (IgG)/immunoglobulin M (IgM) test kit.

Based in San Diego, CA, Confirm BioSciences is the largest North American distributor of Healgen Scientific a subsidiary of Zhejiang Orient Gene Biotech, the test's manufacturer. The test can be used with whole blood, serum, or plasma samples.

The plan is to make "millions of tests available, enough to satisfy existing pre-orders and future orders," Confirm BioSciences said in a statement.

Page 1 of 137
Next Page