FDA product code DHQ: Ng3m(G), Antigen, Antiserum, Control
DHQ is the FDA product code for ng3m(g), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Immunology panel. Devices under DHQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ng3m(G), Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5065 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for DHQ devices
openFDA lists no recalls for product code DHQ.
Frequently asked questions
What is FDA product code DHQ?
DHQ is the FDA product code for ng3m(g), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Immunology panel.
What device class is DHQ?
Class I, regulation 21 CFR 866.5065. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code DHQ
- Run a recall and safety report across every DHQ manufacturer
- Watch product code DHQ 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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