QTE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Thymidine Kinase Activity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- FDA definition
- In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
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| Record | Firm | Date |
|---|---|---|
| DiviTum TKa (K202852) | Biovica International AB | 2022-07-29 |
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Every clearance here is in the API, with alerts when new ones post.