FDA product code DAI: Complement C1r, Antigen, Antiserum, Control
DAI is the FDA product code for complement c1r, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. Devices under DAI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Complement C1r, 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 DAI devices
openFDA lists no recalls for product code DAI.
Frequently asked questions
What is FDA product code DAI?
DAI is the FDA product code for complement c1r, 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 DAI?
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 DAI
- Run a recall and safety report across every DAI manufacturer
- Watch product code DAI 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.
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