Product code
NQI: System, immunomagnetic, circulating cancer cell, enumeration
FDA product code · Class II · Pathology
Key facts
| Product code | NQI |
|---|---|
| Device | System, immunomagnetic, circulating cancer cell, enumeration |
| Device class | Class II |
| Regulation number | 866.6020 |
| Review panel | Pathology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival. |
At a glance
- 10–99 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 10–99 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