Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm - HSA Registration DE0510389
Access comprehensive regulatory information for Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510389 and owned by Roche Diagnostics GmbH. The device was registered on February 25, 2025.
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The uPath HER2 Dual ISH image analysis for Breast algorithm is intended for use as an aid to the pathologist to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17, in formalin-fixed, paraffin-embedded neoplastic breast tissue specimens. When used with the VENTANA HER2 Dual ISH Assay, it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) treatment is being considered.