FDA product code MZI: Test, Qualitative, For Hla, Non-Diagnostic
MZI is the FDA product code for test, qualitative, for hla, non-diagnostic. It is a Unclassified device, reviewed by the Hematology panel. Devices under MZI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Qualitative, For Hla, Non-Diagnostic |
| Device class | Unclassified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Recalls for MZI devices
openFDA lists no recalls for product code MZI.
Frequently asked questions
What is FDA product code MZI?
MZI is the FDA product code for test, qualitative, for hla, non-diagnostic. It is a Unclassified device, reviewed by the Hematology panel.
What device class is MZI?
Unclassified. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MZI
- Run a recall and safety report across every MZI manufacturer
- Watch product code MZI 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.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times