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Snapshot 2026-10-12 · Link to EUDAMED

Oncotype DX Breast Recurrence Score® Kit

UDI-DI 00852867008046Basic UDI-DI 0852867008100406DG

Class C · IVDR · Genomic Health Inc.

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Identification

Model: —
EMDN: W010699
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

Genomic Health Inc.

SRN US-MF-000018730

US · Redwood City

manufacturer

Authorised representative: QbD RepS BV (BE-AR-000000040)

Related UDI-DIs

Oncotype DX Breast Recurrence Score® Computational Software 00852867008022
Oncotype DX Breast Recurrence Score® Kit 00852867008039

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/oncotype-dx-breast-recurrence-score-kit-8046 · UDI page: /udi/00852867008046

All devices from Genomic Health Inc.

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