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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device integrated continuous glucose monitoring system for professional retrospective use
Definition An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.
Product CodeQDL
Regulation Number 862.1355
Device Class 2

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