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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-19 · Link to EUDAMED

LeukoStrat CDx FLT3 Mutation Assay

UDI-DI 00810022732557Basic UDI-DI 081002273K41204314J

Class C · IVDR · Invivoscribe, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
discontinued
Sterile
No
Certificates

IVDR 752181

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2024-10-01 · Expiry 2028-05-06

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Invivoscribe, Inc.

SRN US-MF-000011736

US · San Diego

manufacturer

Authorised representative: IN VIVOSCRIBE TECHNOLOGIES (FR-AR-000003774)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/leukostrat-cdx-flt3-mutation-assay-2557 · UDI page: /udi/00810022732557

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