FDA product code DDN: Beta-2-Glycoprotein I, Antigen, Antiserum, Control
DDN is the FDA product code for beta-2-glycoprotein i, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5430 and reviewed by the Immunology panel. Devices under DDN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Beta-2-Glycoprotein I, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5430 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DDN devices
openFDA lists no recalls for product code DDN.
Frequently asked questions
What is FDA product code DDN?
DDN is the FDA product code for beta-2-glycoprotein i, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5430 and reviewed by the Immunology panel.
What device class is DDN?
Class I, regulation 21 CFR 866.5430. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DDN
- Run a recall and safety report across every DDN manufacturer
- Watch product code DDN 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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