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First At-Home COVID-19 Serology Test From Symbiotica Granted EUA By FDA

April 6, 2021

The US Food and Drug Administration on Monday granted Emergency Use Authorization for Symbiotica's COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.

"The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. 

 
 

Bringing Clinical Testing Closer to Patients

 
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