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FDA product code QTE

Thymidine Kinase Activity

ImmunologyClass 221 CFR 866.6010
Verified
US regulatory classifications
US Product Code (FDA)
QTE
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.6010
View 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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01Thymidine kinase02TK activity03Enzyme assay04Diagnostic test05Tumor marker06Cancer test07Proliferation marker08Clinical assay09Lab test10Cell growth
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.