FDA product code CZR: Hemopexin, Rhodamine, Antigen, Antiserum, Control
CZR is the FDA product code for hemopexin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5490 and reviewed by the Immunology panel. Devices under CZR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hemopexin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5490 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for CZR devices
openFDA lists no recalls for product code CZR.
Frequently asked questions
What is FDA product code CZR?
CZR is the FDA product code for hemopexin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5490 and reviewed by the Immunology panel.
What device class is CZR?
Class II, regulation 21 CFR 866.5490. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CZR
- Run a recall and safety report across every CZR manufacturer
- Watch product code CZR 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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