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Breast Milk Macronutrients Test System

FDA product code QEI · Class 2 · Clinical Chemistry

3
Registered devices
0
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

Miris Check™ — Miris ABMiris Human Milk Analyzer™ — Miris ABMiris Cleaner™ — Miris AB

Recent recalls

DateFirmReason
2022-03-16Stanbio Laboratory, LPThe device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validat

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.