FDA product code MUT: Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)
MUT is the FDA product code for kit, test for nuclear matrix (numa) protein (for monitoring and management of colorectal cancer). It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. Devices under MUT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer) |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MUT devices
openFDA lists no recalls for product code MUT.
Frequently asked questions
What is FDA product code MUT?
MUT is the FDA product code for kit, test for nuclear matrix (numa) protein (for monitoring and management of colorectal cancer). It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is MUT?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MUT
- Run a recall and safety report across every MUT manufacturer
- Watch product code MUT 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.