FDA product code DGA: Cohn Fraction Ii, Antigen, Antiserum, Control
DGA is the FDA product code for cohn fraction ii, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5220 and reviewed by the Immunology panel. Devices under DGA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cohn Fraction Ii, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5220 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DGA devices
openFDA lists no recalls for product code DGA.
Frequently asked questions
What is FDA product code DGA?
DGA is the FDA product code for cohn fraction ii, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5220 and reviewed by the Immunology panel.
What device class is DGA?
Class I, regulation 21 CFR 866.5220. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DGA
- Run a recall and safety report across every DGA manufacturer
- Watch product code DGA 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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