FDA product code DBC: Alpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control
DBC is the FDA product code for alpha 2, 2n-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5425 and reviewed by the Immunology panel. Devices under DBC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Alpha 2, 2n-Glycoprotein, 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 DBC devices
openFDA lists no recalls for product code DBC.
Frequently asked questions
What is FDA product code DBC?
DBC is the FDA product code for alpha 2, 2n-glycoprotein, 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 DBC?
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 DBC
- Run a recall and safety report across every DBC manufacturer
- Watch product code DBC 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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