QEI — Breast Milk Macronutrients Test System Class II
Classification Details
- Product Code
- QEI
- Device Class
- Class II
- Regulation Number
- 862.1493
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.