www.fdanews.com/articles/198363-siemens-healthineers-gets-eua-for-semi-quantitative-antibody-test
Siemens Healthineers’ Gets EUA for Semi-Quantitative Antibody Test
August 5, 2020
The FDA has granted Siemens Healthineers an Emergency Use Authorization for a semi-quantitative SARS-CoV-2 IgG antibody test.
The antibody test is the first authorized by the FDA that gives clinicians the ability to gauge the level of IgG antibodies present in a blood sample.
The test will help to establish the level of IgG antibodies that may be protective against the coronavirus, the company said.