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FDA PRODUCT CODE · CLASS II

QTE — Thymidine Kinase Activity

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

DEVICE CLASS
Class II
REGULATION
21 CFR 866.6010
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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