FDA product code NVA: Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma
NVA is the FDA product code for cancer monitoring test system, soluble mesothelin-related peptides, mesothelioma. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. Devices under NVA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.
Classification
| Field | Value |
|---|---|
| Device name | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma |
| 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 NVA devices
openFDA lists no recalls for product code NVA.
Frequently asked questions
What is FDA product code NVA?
NVA is the FDA product code for cancer monitoring test system, soluble mesothelin-related peptides, mesothelioma. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is NVA?
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 NVA
- Run a recall and safety report across every NVA manufacturer
- Watch product code NVA 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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