Product code QEI

Device name

Breast Milk Macronutrients Test System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1493

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset