FDA product code MZH: Test, Quantitative, For Hla, Non-Diagnostic
MZH is the FDA product code for test, quantitative, for hla, non-diagnostic. It is a Not classified device, reviewed by the Hematology panel. Devices under MZH reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test, Quantitative, For Hla, Non-Diagnostic |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MZH devices
openFDA lists no recalls for product code MZH.
Frequently asked questions
What is FDA product code MZH?
MZH is the FDA product code for test, quantitative, for hla, non-diagnostic. It is a Not classified device, reviewed by the Hematology panel.
What device class is MZH?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MZH
- Run a recall and safety report across every MZH manufacturer
- Watch product code MZH 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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