Test Classification Current Value

This test was developed and its performance characteristics were determined and validated by the Clinical Mass Spectrometry Laboratory at Cincinnati Childrens Hospital Medical Center. It has not been cleared or approved by the U. S. Food and Drug Administration. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) as qualified to perform high-complexity laboratory testing.

Test Classification Value Prior to 1/24/2020 4:02pm

This test was developed and its performance characteristics were determined and validated by the Clinical Mass Spectrometry Laboratory at Cincinnati Childrens Hospital Medical Center. It has not been cleared or approved by the U. S. Food and Drug Administration.