FDA product code MGU: Fluorescence Polarization Immunoassay For Cyclosporine
MGU is the FDA product code for fluorescence polarization immunoassay for cyclosporine. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel. Devices under MGU reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for MGU devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay 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 MGU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-03-23.
Frequently asked questions
What is FDA product code MGU?
MGU is the FDA product code for fluorescence polarization immunoassay 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 MGU?
Class II, regulation 21 CFR 862.1235. Typical premarket route: 510(k).
Have MGU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MGU
- Run a recall and safety report across every MGU manufacturer
- Watch product code MGU 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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