FDA product code DNA: Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody
DNA is the FDA product code for radioimmunoassay, morphine-barbiturate (125-i), goat antibody. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. Devices under DNA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DNA devices
openFDA lists no recalls for product code DNA.
Frequently asked questions
What is FDA product code DNA?
DNA is the FDA product code for radioimmunoassay, morphine-barbiturate (125-i), goat antibody. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DNA?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DNA
- Run a recall and safety report across every DNA manufacturer
- Watch product code DNA 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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