Test Classification Current Value

This test was developed and its performance characteristics determined by the UCH Clinical Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. 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 Amendment of 1988 ("CLIA") as qualified to perform hig complexity clinical testing.

Test Classification Value Prior to 1/16/2023 10:01am

This test was developed and its performance characteristics determined by the UCH Clinical Laboratory. It has not been cleared or approved by U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. 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 Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.