FDA product code DEZ: Igm, Rhodamine, Antigen, Antiserum, Control
DEZ is the FDA product code for igm, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. Devices under DEZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Igm, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DEZ devices
openFDA lists no recalls for product code DEZ.
Frequently asked questions
What is FDA product code DEZ?
DEZ is the FDA product code for igm, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DEZ?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DEZ
- Run a recall and safety report across every DEZ manufacturer
- Watch product code DEZ 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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