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Basic Information
- Primary DI
- 04262370480035
- Basic UDI-DI Code
- B-04262370480035
- Reference
- HER2 Quantifier clinical
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- VMscope GmbH
Additional Description
HER2 Quantifier clinical is a standalone software to support the determination of the HER2 index in breast tumors. The analyte on which the analysis is based is the HER2 protein. The aim of the Analysis is to provide information to assist in the detection of tumor cells, the determination of the number of negatively stained tumor cells, the number of HER2 positively stained tumor cells per class 1+, 2+ and 3+ and the ratio of positively stained tumor cells per class 1+, 2+ and 3+ for the total number of tumor cells.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02029092 | VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE |
Available In Countries
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