FDA product code CZO: Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control
CZO is the FDA product code for inter-alpha trypsin inhibitor, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5890 and reviewed by the Immunology panel. Devices under CZO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Inter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5890 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for CZO devices
openFDA lists no recalls for product code CZO.
Frequently asked questions
What is FDA product code CZO?
CZO is the FDA product code for inter-alpha trypsin inhibitor, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5890 and reviewed by the Immunology panel.
What device class is CZO?
Class I, regulation 21 CFR 866.5890. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CZO
- Run a recall and safety report across every CZO manufacturer
- Watch product code CZO 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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