FDA product code CZT: Hemopexin, Fitc, Antigen, Antiserum, Control
CZT is the FDA product code for hemopexin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5490 and reviewed by the Immunology panel. Devices under CZT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hemopexin, Fitc, 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 CZT devices
openFDA lists no recalls for product code CZT.
Frequently asked questions
What is FDA product code CZT?
CZT is the FDA product code for hemopexin, fitc, 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 CZT?
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 CZT
- Run a recall and safety report across every CZT manufacturer
- Watch product code CZT 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.