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This test uses a device labeled by the manufacturer as Investigational Use Only. The performance characteristics were determined by Marshfield Labs in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commerical payers, prior authorization should be obtained.
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