FDA product code DNW: Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.
DNW is the FDA product code for radioimmunoassay, digitoxin (3-h), rabbit antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. Devices under DNW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3300 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DNW devices
openFDA lists no recalls for product code DNW.
Frequently asked questions
What is FDA product code DNW?
DNW is the FDA product code for radioimmunoassay, digitoxin (3-h), rabbit antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is DNW?
Class II, regulation 21 CFR 862.3300. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DNW
- Run a recall and safety report across every DNW manufacturer
- Watch product code DNW 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times