FDA product code MAR: Cyclosporine And Metabolites Serum Assay
MAR is the FDA product code for cyclosporine and metabolites serum assay. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel. Devices under MAR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cyclosporine And Metabolites Serum Assay |
| 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 MAR devices
openFDA lists no recalls for product code MAR.
Frequently asked questions
What is FDA product code MAR?
MAR is the FDA product code for cyclosporine and metabolites serum assay. It is a Class II device, regulated under 21 CFR 862.1235 and reviewed by the Clinical Toxicology panel.
What device class is MAR?
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 MAR
- Run a recall and safety report across every MAR manufacturer
- Watch product code MAR 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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