FDA product code MZE: Test, Donor, Cmv
MZE is the FDA product code for test, donor, cmv. It is a Class II device, reviewed by the Immunology panel. Devices under MZE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Donor, Cmv |
| Device class | Class II |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for MZE devices
openFDA lists no recalls for product code MZE.
Frequently asked questions
What is FDA product code MZE?
MZE is the FDA product code for test, donor, cmv. It is a Class II device, reviewed by the Immunology panel.
What device class is MZE?
Class II. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MZE
- Run a recall and safety report across every MZE manufacturer
- Watch product code MZE 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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