FDA product code DFX: Sperm, Fitc, Antigen, Antiserum, Control
DFX is the FDA product code for sperm, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5800 and reviewed by the Immunology panel. Devices under DFX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Sperm, Fitc, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5800 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DFX devices
openFDA lists no recalls for product code DFX.
Frequently asked questions
What is FDA product code DFX?
DFX is the FDA product code for sperm, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5800 and reviewed by the Immunology panel.
What device class is DFX?
Class I, regulation 21 CFR 866.5800. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DFX
- Run a recall and safety report across every DFX manufacturer
- Watch product code DFX 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.