FDA product code DDL: Thyroglobulin, Rhodamine, Antigen, Antiserum, Control
DDL is the FDA product code for thyroglobulin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel. Devices under DDL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Thyroglobulin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5870 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DDL devices
openFDA lists no recalls for product code DDL.
Frequently asked questions
What is FDA product code DDL?
DDL is the FDA product code for thyroglobulin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel.
What device class is DDL?
Class II, regulation 21 CFR 866.5870. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DDL
- Run a recall and safety report across every DDL manufacturer
- Watch product code DDL 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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