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  Physician's Guide

Compliance Statements

Compliance Statement A

ASR Compliance Statement

Analyte Specific Reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been approved or cleared by the U.S. Food and Drug Administration. This test should not be regarded as investigational or for research use.

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.

Compliance Statement C

Genetic Compliance Statement

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. However, FDA approval or clearance is currently not required for clinical use of 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.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online.

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

Compliance Statement E

The manufacturer has not determined the efficacy of this test when performed on CSF specimens. The performance characteristics of this test were determined by ARUP laboratories.