Test Classification Current Value

This test was developed and its performance characteristics determined by Versiti Wisconsin, Inc. It has not been cleared or approved by the US Food and Drug Administration. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.

Test Classification Value Prior to 2/01/2019 8:01pm

These tests were developed and their performance characteristics were determined by BloodCenter of Wisconsin. They have not been cleared by the FDA. However, this approval is not required.