ARUP refers to this statement on their website.
Compliance Statement D: Commercial “Research Use” Kit Compliance Statement: This test uses a kit designated by the manufacturer as “for research use, not for clinical use.” The performance characteristics of this test were validated by ARUP Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. ARUP is authorized under Clinical Laboratory Improvement Amendments (CLIA) and by all states to perform high-complexity testing.