FDA product code DAG: Complement C8, Antigen, Antiserum, Control
DAG is the FDA product code for complement c8, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. Devices under DAG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Complement C8, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DAG devices
openFDA lists no recalls for product code DAG.
Frequently asked questions
What is FDA product code DAG?
DAG is the FDA product code for complement c8, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is DAG?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DAG
- Run a recall and safety report across every DAG manufacturer
- Watch product code DAG 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.