FDA product code DIQ: Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.
DIQ is the FDA product code for radioimmunoassay, morphine (3-h), goat antibody ammonium sulfate sep.. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. Devices under DIQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. |
| 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 DIQ devices
openFDA lists no recalls for product code DIQ.
Frequently asked questions
What is FDA product code DIQ?
DIQ is the FDA product code for radioimmunoassay, morphine (3-h), goat antibody ammonium sulfate sep.. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DIQ?
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 DIQ
- Run a recall and safety report across every DIQ manufacturer
- Watch product code DIQ 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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