FDA product code QEI

Breast Milk Macronutrients Test System

Clinical Chemistry·Class 2·21 CFR 862.1493
US regulatory classifications
US Product Code (FDA)
QEI
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1493
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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 breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants.

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About this record

Breast Milk Macronutrients Test System 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.