Test Classification Current Value

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.

Test Classification Value Prior to 6/12/2020 4:03pm

Results of this test are for research purposes only per the assay manufacturer. The performance characteristics of this assay have not been established. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.