FDA product code DBH: Fc, Rhodamine, Antigen, Antiserum, Control
DBH is the FDA product code for fc, rhodamine, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel. Devices under DBH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fc, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5530 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DBH devices
openFDA lists no recalls for product code DBH.
Frequently asked questions
What is FDA product code DBH?
DBH is the FDA product code for fc, rhodamine, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5530 and reviewed by the Immunology panel.
What device class is DBH?
Class I, regulation 21 CFR 866.5530. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DBH
- Run a recall and safety report across every DBH manufacturer
- Watch product code DBH 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.