This assay should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P).
Compliance Statement B
: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.