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Breast Milk Macronutrients Test System

FDA product code QEI · 2 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1493
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-09-29 – 2024-05-03

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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