FDA product code QTE
Thymidine Kinase Activity
Immunology·Class 2·21 CFR 866.6010
US regulatory classifications
- US Product Code (FDA)
- QTEView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.6010View CFR Regulation →
- Medical specialty
- Immunology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
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About this record
Thymidine Kinase Activity is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.