Test Classification Current Value

The performance characteristics for this test have been validated by National Jewish Health. It has not been cleared or approved by the U.S. Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

Test Classification Value Prior to 4/23/2024 10:04am

This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics for this test have been validated by National Jewish Health. It has not been cleared or approved by the U.S. Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinival laboratory testing.