FDA product code DAX: Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control
DAX is the FDA product code for fibrinogen and split products, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. Devices under DAX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 864.7340 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DAX devices
openFDA lists no recalls for product code DAX.
Frequently asked questions
What is FDA product code DAX?
DAX is the FDA product code for fibrinogen and split products, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is DAX?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DAX
- Run a recall and safety report across every DAX manufacturer
- Watch product code DAX 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.