FDA product code DAJ: Free Secretory Component, Antigen, Antiserum, Control
DAJ is the FDA product code for free secretory component, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5380 and reviewed by the Immunology panel. Devices under DAJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Free Secretory Component, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5380 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DAJ devices
openFDA lists no recalls for product code DAJ.
Frequently asked questions
What is FDA product code DAJ?
DAJ is the FDA product code for free secretory component, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5380 and reviewed by the Immunology panel.
What device class is DAJ?
Class II, regulation 21 CFR 866.5380. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DAJ
- Run a recall and safety report across every DAJ manufacturer
- Watch product code DAJ 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.