País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD.
Class C IVD
Menarini Silicon Biosystems Inc.
Pathology
The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
Models: CellSearch® Circulating Tumor Cell Kit - 7900001, CellSearch® Circulating Tumor Cell Control Kit - 7900003, CellSave Preservative Tubes(100-pack) - 7900005, CellSave Preservative Tubes(20-pack) - 952820, CellTracks®AutoPrep® System - 9541, CellTracks®AutoPrep® Instrument Buffer - 7901003, CellTracks Analyzer II® - 9555
2011-03-01