No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

ARK Ketamine Assay

UDI-DI 00812101030004Basic UDI-DI 0858724003KET0563D

Class B · IVDR · ARK Diagnostics, Inc.

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Identification

Model: 5056-0001-00
EMDN: W0102090199
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

ARK Diagnostics, Inc.

SRN US-MF-000023925

US · Fremont

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

ARK Ketamine Assay 00812101030011
ARK Ketamine Calibrator 00812101030028
ARK Ketamine Calibrator 00812101030042
ARK Ketamine Calibrator 00812101030035
ARK Ketamine Control 00812101030059

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ark-ketamine-assay-0004 · UDI page: /udi/00812101030004

All devices from ARK Diagnostics, Inc.

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