FDA product code DGM: Breast Milk, Antigen, Antiserum, Control
DGM is the FDA product code for breast milk, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5170 and reviewed by the Immunology panel. Devices under DGM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Breast Milk, 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 DGM devices
openFDA lists no recalls for product code DGM.
Frequently asked questions
What is FDA product code DGM?
DGM is the FDA product code for breast milk, 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 DGM?
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 DGM
- Run a recall and safety report across every DGM manufacturer
- Watch product code DGM 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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