![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Grants Emergency Clearance for Symbiotica’s COVID-19 Antibody Test
FDA Grants Emergency Clearance for Symbiotica’s COVID-19 Antibody Test
![emergency use authorization approved](https://www.fdanews.com/ext/resources/test/Drug-Images4/emergency-use-authorization-EUA-approved.gif?t=1586211479&width=430)
April 7, 2021
The FDA has granted Emergency Use Authorization for Symbiotica’s COVID-19 antibody test, its first authorization for a test that uses self-collected dried blood samples.
The antibody test is now cleared for use with blood-spot samples collected by patients at home using a fingerstick and sent to a Symbiotica laboratory for analysis.
The test is meant to help identify patients who have generated an immune response to SARS-CoV-2, which indicates they have previously been infected. It should not be used to diagnose or exclude acute infection, the agency said.
Upcoming Events
-
21Oct