Test Classification Current Value

This test was developed and its performance characteristics determined by MiraVista Diagnostics. It has not been cleared or approved by the FDA; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Test Classification Value Prior to 10/12/2023 3:01pm

This test was developed and its performance characteristics determined by MiraVista Diagnostics. It has not been cleared or approved by the FDA; however, FDA clearance or approval is not currently required for clinical use. The results are intended to be used as the sole means for clinical diagnosis or patient management decisions.