FDA product code DOW: Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube
DOW is the FDA product code for radioimmunoassay, digitoxin (3-h), rabbit antibody, coated tube. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. Devices under DOW 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, Coated Tube |
| 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 DOW devices
openFDA lists no recalls for product code DOW.
Frequently asked questions
What is FDA product code DOW?
DOW is the FDA product code for radioimmunoassay, digitoxin (3-h), rabbit antibody, coated tube. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is DOW?
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 DOW
- Run a recall and safety report across every DOW manufacturer
- Watch product code DOW 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