Ki-67 Quantifier clinical

Organization name

VMscope GmbH

SRN

DE-MF-000023540

Manufacturer status

Active

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• CW010

  respect the IFU and requirements

Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

04262370480011

Basic UDI-DI

B-04262370480011

Reference / catalog number

Ki-67 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

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.

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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