HER2 Quantifier clinical

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

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).