FDA product code DNQ: Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.
DNQ is the FDA product code for radioimmunoassay, digoxin (3-h), rabbit antibody, coated tubes sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. Devices under DNQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DNQ devices
openFDA lists no recalls for product code DNQ.
Frequently asked questions
What is FDA product code DNQ?
DNQ is the FDA product code for radioimmunoassay, digoxin (3-h), rabbit antibody, coated tubes sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DNQ?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DNQ
- Run a recall and safety report across every DNQ manufacturer
- Watch product code DNQ 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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