FDA product code MSZ: Strip, Test, Reagent, Residuals For Dialysate
MSZ is the FDA product code for strip, test, reagent, residuals for dialysate. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel. Devices under MSZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Strip, Test, Reagent, Residuals For Dialysate |
| Device class | Class II |
| Regulation | 21 CFR 876.5665 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for MSZ devices
openFDA lists no recalls for product code MSZ.
Frequently asked questions
What is FDA product code MSZ?
MSZ is the FDA product code for strip, test, reagent, residuals for dialysate. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel.
What device class is MSZ?
Class II, regulation 21 CFR 876.5665. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MSZ
- Run a recall and safety report across every MSZ manufacturer
- Watch product code MSZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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