A Certificate of Waiver authorizes a laboratory to perform which type of tests?

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Multiple Choice

A Certificate of Waiver authorizes a laboratory to perform which type of tests?

Explanation:
With a Certificate of Waiver, a laboratory is authorized to perform only waived tests. Waived tests are simple, low-risk procedures that have been FDA-cleared as waived and can be performed with minimal complexity and oversight when following the kit instructions. This means the lab cannot perform moderate- or high-complexity tests or all laboratory tests under this certificate; those require a different CLIA certificate or accreditation. In short, the certificate confines the lab to the waived category, not to more complex testing.

With a Certificate of Waiver, a laboratory is authorized to perform only waived tests. Waived tests are simple, low-risk procedures that have been FDA-cleared as waived and can be performed with minimal complexity and oversight when following the kit instructions. This means the lab cannot perform moderate- or high-complexity tests or all laboratory tests under this certificate; those require a different CLIA certificate or accreditation. In short, the certificate confines the lab to the waived category, not to more complex testing.

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