Product code
NVA: Cancer monitoring test system, soluble mesothelin-related peptides, mesothelioma
FDA product code · Class II · Immunology
Key facts
| Product code | NVA |
|---|---|
| Device | Cancer monitoring test system, soluble mesothelin-related peptides, mesothelioma |
| Device class | Class II |
| Regulation number | 866.6010 |
| Review panel | Immunology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database