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Laboratory Test Complexity - Waived, Moderate and High
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How can I verify the test complexity designation for a particular laboratory test?

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Any examples are for illustrative purposes only.
 
Commercial test systems are evaluated by the Food and Drug Administration (FDA) and assigned one of the three following complexity designations: Waived Moderate High Moderate and High complexity are often referred to as "non-waived" testing. The complexity designation may be printed in the manufacturer's package insert. It can also be searched online in the FDA's database:
Manual: Office Based Surgery
Chapter: Waived Testing WT
First published date: April 11, 2016 This Standards FAQ was first published on this date.
This page was last updated on November 01, 2021
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