MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit

Organization name

Agendia N.V

SRN

NL-MF-000011684

Manufacturer status

Active

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• CW011

  EUDAMED did not publish a description for this code.
• CW007

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• CW090

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• CW018

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• CW132

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Primary placement in Belgium; available across 1 country total.

Trade name

MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit

UDI-DI code

00850024841352

Basic UDI-DI

085002484193128042

Reference / catalog number

931280

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit is a qualitative, non-automated in vitro diagnostic test, for use by clinical laboratories, using target enrichment Next Generation Sequencing (NGS) for gene expression assessment on formalin-fixed paraffin embedded (FFPE) female breast cancer tissue samples to assess a patient’s risk for distant metastasis and determination of the molecular subtype. MammaPrint and BluePrint provide information regarding prediction of the magnitude of systemic therapy benefit to guide treatment decisions in patients with breast cancer.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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• Expiration date
• Manufacturing date
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• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W05039099DEVICES FOR SAMPLES ANALYSES - OTHER