FDA product code QRX

Continuous Glucose Monitor Informed Insulin Dose Calculator

Clinical Chemistry·Class 2·21 CFR 862.1358
US regulatory classifications
US Product Code (FDA)
QRX
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1358
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.

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About this record

Continuous Glucose Monitor Informed Insulin Dose Calculator 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.