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Food and Drug Administration Cleared or Approved Test System (FDA Cleared or Approved Test System)

Date of Publication:

5/29/2014

Definition:

A test system cleared or approved by the FDA through the premarket notification or premarket approval process for in vitro diagnostic use. Unless otherwise stated, this includes test systems exempt from FDA premarket clearance or approval.

Source of Definition:

Clinical Laboratory Improvement Program CLIP Procedures

Related Glossary Terms:

Food and Drug Administration Cleared or Approved Test System

Last Updated: November 21, 2022
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