FDA product code DAR: Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control
DAR is the FDA product code for fibrinogen and split products, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. Devices under DAR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fibrinogen And Split Products, Rhodamine, 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 DAR devices
openFDA lists no recalls for product code DAR.
Frequently asked questions
What is FDA product code DAR?
DAR is the FDA product code for fibrinogen and split products, rhodamine, 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 DAR?
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 DAR
- Run a recall and safety report across every DAR manufacturer
- Watch product code DAR 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.