FDA product code MGS: High Performance Liquid Chromatography For Cyclosporine
MGS is the FDA product code for high performance liquid chromatography for cyclosporine. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel. Devices under MGS 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 | High Performance Liquid Chromatography 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 MGS devices
openFDA lists no recalls for product code MGS.
Frequently asked questions
What is FDA product code MGS?
MGS is the FDA product code for high performance liquid chromatography 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 MGS?
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 MGS
- Run a recall and safety report across every MGS manufacturer
- Watch product code MGS 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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