FDA product code DDO: Myoglobin, Rhodamine, Antigen, Antiserum, Control
DDO is the FDA product code for myoglobin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel. Devices under DDO reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Myoglobin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5680 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DDO devices
openFDA lists no recalls for product code DDO.
Frequently asked questions
What is FDA product code DDO?
DDO is the FDA product code for myoglobin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel.
What device class is DDO?
Class II, regulation 21 CFR 866.5680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DDO
- Run a recall and safety report across every DDO manufacturer
- Watch product code DDO 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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