FDA product code DGN: Breast Milk, Fitc, Antigen, Antiserum, Control
DGN is the FDA product code for breast milk, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5170 and reviewed by the Immunology panel. Devices under DGN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Breast Milk, Fitc, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5170 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DGN devices
openFDA lists no recalls for product code DGN.
Frequently asked questions
What is FDA product code DGN?
DGN is the FDA product code for breast milk, fitc, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5170 and reviewed by the Immunology panel.
What device class is DGN?
Class I, regulation 21 CFR 866.5170. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DGN
- Run a recall and safety report across every DGN manufacturer
- Watch product code DGN 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.