BABiovica International AB · Model 95010
DiviTumTKa is an in vitro diagnostic device intended for the semi-quantitative measurement of thymidine kinase activity (TKa) in human serum. The assay is to be used as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients. A TKa value of < 250 DuA is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. DiviTumTKa results should be used in conjunction with other clinical methods for monitoring breast cancer.
Intended use: A collection of reagents and other associated materials intended to be used for the quantitative measurement of thymidine kinase in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a prognostic marker to monitor the progression of haematological malignancies [e.g., non-Hodgkin lymphoma, chronic lymphocytic leukaemia (CLL)] and assess the response to treatment.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
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