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Thymidine Kinase Activity

FDA product code QTE · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6010
Review panel
IM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-07-29 – 2022-07-29

In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.

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