FDA product code DEJ: Alpha-2-Glycoproteins, Antigen, Antiserum, Control
DEJ is the FDA product code for alpha-2-glycoproteins, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5425 and reviewed by the Immunology panel. Devices under DEJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-2-Glycoproteins, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5425 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DEJ devices
openFDA lists no recalls for product code DEJ.
Frequently asked questions
What is FDA product code DEJ?
DEJ is the FDA product code for alpha-2-glycoproteins, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5425 and reviewed by the Immunology panel.
What device class is DEJ?
Class I, regulation 21 CFR 866.5425. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DEJ
- Run a recall and safety report across every DEJ manufacturer
- Watch product code DEJ 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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