Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 04262370480028
- Basic UDI-DI Code
- B-04262370480028
- Reference
- ER-PR Quantifier clinical
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- VMscope GmbH
Additional Description
ER-PR Quantifier clinical is a standalone software to support the determination of the estrogen or progesterone receptor index in breast tumors. The aim of the analysis is to provide information to support the detection of tumor cell nuclei, the classification into ER or PR-positive and negative tumor cells and the determination of the ER or PR index.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02029092 | VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE |
Available In Countries
🇦🇹 Austria
🇩🇪 Germany
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries