FDA product code MGV: Radioimmunoassay For Cyclosporine
MGV is the FDA product code for radioimmunoassay for cyclosporine. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel. Devices under MGV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay For Cyclosporine |
| Device class | Class II |
| Regulation | 21 CFR 862.1235 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MGV devices
openFDA lists no recalls for product code MGV.
Frequently asked questions
What is FDA product code MGV?
MGV is the FDA product code for radioimmunoassay for cyclosporine. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel.
What device class is MGV?
Class II, regulation 21 CFR 862.1235. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MGV
- Run a recall and safety report across every MGV manufacturer
- Watch product code MGV 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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