FDA product code DFJ: Albumin, Rhodamine, Antigen, Antiserum, Control
DFJ is the FDA product code for albumin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5040 and reviewed by the Immunology panel. Devices under DFJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Albumin, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5040 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DFJ devices
openFDA lists no recalls for product code DFJ.
Frequently asked questions
What is FDA product code DFJ?
DFJ is the FDA product code for albumin, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5040 and reviewed by the Immunology panel.
What device class is DFJ?
Class II, regulation 21 CFR 866.5040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DFJ
- Run a recall and safety report across every DFJ manufacturer
- Watch product code DFJ 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.