FDA product code MVD: System, Test, Her-2/Neu, Nucleic Acid Or Serum
MVD is the FDA product code for system, test, her-2/neu, nucleic acid or serum. It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Pathology panel. Devices under MVD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Her-2/Neu, Nucleic Acid Or Serum |
| Device class | Class II |
| Regulation | 21 CFR 864.1890 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
Recalls for MVD devices
openFDA lists no recalls for product code MVD.
Frequently asked questions
What is FDA product code MVD?
MVD is the FDA product code for system, test, her-2/neu, nucleic acid or serum. It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Pathology panel.
What device class is MVD?
Class II, regulation 21 CFR 864.1890. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MVD
- Run a recall and safety report across every MVD manufacturer
- Watch product code MVD 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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