FDA product code DEA: Myoglobin, Fitc, Antigen, Antiserum, Control
DEA is the FDA product code for myoglobin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel. Devices under DEA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Myoglobin, Fitc, 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 DEA devices
openFDA lists no recalls for product code DEA.
Frequently asked questions
What is FDA product code DEA?
DEA is the FDA product code for myoglobin, fitc, 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 DEA?
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 DEA
- Run a recall and safety report across every DEA manufacturer
- Watch product code DEA 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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