HER2 Quantifier clinical

Organization name

VMscope GmbH

SRN

DE-MF-000023540

Manufacturer status

Active

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• CW010

  Consult Instructions For Use

Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

04262370480035

Basic UDI-DI

B-04262370480035

Reference / catalog number

HER2 Quantifier clinical

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02029092VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

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