FDA product code CZL: Iga, Peroxidase, Antigen, Antiserum, Control
CZL is the FDA product code for iga, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. Devices under CZL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Iga, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CZL devices
openFDA lists no recalls for product code CZL.
Frequently asked questions
What is FDA product code CZL?
CZL is the FDA product code for iga, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CZL?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CZL
- Run a recall and safety report across every CZL manufacturer
- Watch product code CZL 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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