HSA · registration DE0510389Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm
- Registration number
- DE0510389
- Model name
- Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm
- Model identifier
- 09103546001 / 09134433001
- Registration date
- February 25, 2025
- Risk class
- Class C
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
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.
- Product owner address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- Registrant address
- 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.