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Laboratory Test Complexity - Waived, Moderate and High

How can I verify the test complexity designation for a particular laboratory test?

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: Home Care
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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