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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device thymidine kinase activity
Regulation Description Tumor-associated antigen immunological test system.
Definition In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
Product CodeQTE
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOVICA INTERNATIONAL AB
  SUBSTANTIALLY EQUIVALENT 1

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