SIEMENS HEALTHINEERS

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Siemens Healthineers : Gets FDA Emergency Use Authorization for SARS-CoV-2 IgG Antibody Test

08/04/2020 | 08:30am

By Mauro Orru

Siemens Healthineers AG said Tuesday that the U.S. Food and Drug Administration granted emergency use authorization for the SARS-CoV-2 IgG antibody test.

The German medical-equipment maker said the test, which also received the CE-mark and is broadly available globally, is the first antibody test authorized with a semi-quantitative detection claim to support clinicians in assessing the level of an individual's immune response to the coronavirus.

"Our high-quality antibody test helps clinicians assess the level of a person's immune response, which is an important tool to have at this stage of the pandemic," said Deepak Nath, president of laboratory diagnostics for Siemens Healthineers.

 

Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94

 

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