Test Classification Current Value

This test has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration and is modified from the manufacturer's instructions with a bridging study. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

Test Classification Value Prior to 3/04/2021 5:09am

This test has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration and is used per manufacturer's instructions in testing upper respiratory tract specimens, but it is modified from the manufacturer's instructions with a bridging study in testing lower respiratory tract specimens. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.