FDA product code MZL: Kit, Test, Quality Control For Endotoxin
MZL is the FDA product code for kit, test, quality control for endotoxin. It is a Not classified device, reviewed by the Immunology panel. Devices under MZL reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test, Quality Control For Endotoxin |
| Device class | Not classified |
| Review panel | IM — Immunology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MZL devices
openFDA lists no recalls for product code MZL.
Frequently asked questions
What is FDA product code MZL?
MZL is the FDA product code for kit, test, quality control for endotoxin. It is a Not classified device, reviewed by the Immunology panel.
What device class is MZL?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code MZL
- Run a recall and safety report across every MZL manufacturer
- Watch product code MZL 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.