FDA product code QII

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

Clinical Chemistry·Class 2·21 CFR 862.1355
US regulatory classifications
US Product Code (FDA)
QII
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1355
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

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About this record

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.