QEIClass II

Breast Milk Macronutrients Test System

Clinical Chemistry · 21 CFR 862.1493

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.

MDR events0All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances3All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Stanbio Laboratory, LP
TerminatedUnknown
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
Z-0905-2022 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

Miris Ab
Uppsala, SE

510(k) clearances

3 clearances for this product code