FDA product code DOB: Radioimmunoassay, Digitoxin (3-H)
DOB is the FDA product code for radioimmunoassay, digitoxin (3-h). It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. Devices under DOB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digitoxin (3-H) |
| 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 DOB devices
openFDA lists no recalls for product code DOB.
Frequently asked questions
What is FDA product code DOB?
DOB is the FDA product code for radioimmunoassay, digitoxin (3-h). It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is DOB?
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 DOB
- Run a recall and safety report across every DOB manufacturer
- Watch product code DOB 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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