Product code
QTE: Thymidine kinase activity
FDA product code · Class II · Immunology
Key facts
| Product code | QTE |
|---|---|
| Device | Thymidine kinase activity |
| 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 | In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 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