FDA product code DPI: Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.
DPI is the FDA product code for radioimmunoassay, digoxin (125-i), bovine antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. Devices under DPI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal 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 DPI devices
openFDA lists no recalls for product code DPI.
Frequently asked questions
What is FDA product code DPI?
DPI is the FDA product code for radioimmunoassay, digoxin (125-i), bovine antibody, charcoal sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DPI?
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 DPI
- Run a recall and safety report across every DPI manufacturer
- Watch product code DPI 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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