Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 04262370480011
- Basic UDI-DI Code
- B-04262370480011
- Reference
- Ki-67 Quantifier clinical
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- VMscope GmbH
Additional Description
Ki-67 Quantifier clinical is a standalone software that is used for the in vitro examination of digitized microscopic images of histological tissue samples stained with the Ki-67 marker. The aim of the analysis is to provide information to support the detection of tumor cell nuclei, the classification into Ki67-positive and negative tumor cells and the determination of the Ki67 proliferation index. Ki-67 Quantifier clinical is only approved for use in breast tumors. A clinical application for other diseases or entities is therefore excluded.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02029092 | VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE |
Available In Countries
🇦🇹 Austria
🇩🇪 Germany
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