GenASI 染色体Her-2信号计数分析系统

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市场价格：面议

医疗器械

许可证号：国械注进20152702276

上海宇北医疗器械有限公司

详细信息

GenASIs Scan & Analysis (SpotScan) system station

for Detection of HER2/neu Gene Amplification in Breast Cancer Biopsy

ASI自动扫描和分析系统通过结合手动或自动化的显微镜扫描乳腺癌症组织样本来侦测HER-2/neu基因的扩增，实现精确的临床结果诊断。

分析功能

² 扩增量测，including large HSR's

² Green和Red 信号计数的平均值

² 使用者可限制性的界定扩增均值

² 定义限制任一细胞侦测条件，如“每一细胞至少1个Green信号”

² 定义的细胞群可基于扩增的范围

² 低弱背景下检测微弱荧光信号
ASI is FDA cleared for In Vitro Diagnostic procedures of detection of the following:
- GenASIs CEP XY to assess the effectiveness of bone marrow transplantation in opposite-sex transplants
- GenASIs Her2/neu FISH for in vitro diagnosis as an aid to the cytogeneticist/pathologist in the deletion, classification, and counting of cells of interest.
- GenASIs UroVysion for cells in urine specimens stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus, from persons with hematuria suspected of having bladder cancer.

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