FDA product code DCT: Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control
DCT is the FDA product code for ceruloplasmin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel. Devices under DCT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5210 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DCT devices
openFDA lists no recalls for product code DCT.
Frequently asked questions
What is FDA product code DCT?
DCT is the FDA product code for ceruloplasmin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel.
What device class is DCT?
Class II, regulation 21 CFR 866.5210. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DCT
- Run a recall and safety report across every DCT manufacturer
- Watch product code DCT 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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