FDA product code CZZ: Haptoglobin, Rhodamine, Antigen, Antiserum, Control
CZZ is the FDA product code for haptoglobin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5460 and reviewed by the Immunology panel. Devices under CZZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Haptoglobin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5460 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for CZZ devices
openFDA lists no recalls for product code CZZ.
Frequently asked questions
What is FDA product code CZZ?
CZZ is the FDA product code for haptoglobin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5460 and reviewed by the Immunology panel.
What device class is CZZ?
Class II, regulation 21 CFR 866.5460. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CZZ
- Run a recall and safety report across every CZZ manufacturer
- Watch product code CZZ 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.