FDA product code MZG: Test, Residual, Wbc In Leukoreduced Blood
MZG is the FDA product code for test, residual, wbc in leukoreduced blood. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. Devices under MZG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
CBER
Classification
| Field | Value |
|---|---|
| Device name | Test, Residual, Wbc In Leukoreduced Blood |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for MZG devices
openFDA lists no recalls for product code MZG.
Frequently asked questions
What is FDA product code MZG?
MZG is the FDA product code for test, residual, wbc in leukoreduced blood. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is MZG?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MZG
- Run a recall and safety report across every MZG manufacturer
- Watch product code MZG 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.