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Breast Milk Macronutrients Test System

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.

Global Registration Data
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Breast Milk Macronutrients Test System
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QEI

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Class 2

21 CFR 862.1493

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Clinical Chemistry

Device Characteristics

No

No

No

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.