Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 140391. The device is manufactured by ARK Diagnostics, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 140391•Ref: 140391

Device Type

In Vitro Diagnostic Device

Devices

Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

ARK Diagnostics, Inc.

Address

48089 Fremont Blvd

Fremont, California, United States

Created Date

Nov 8, 2021

Authorized Representative

Name

Emergo Consulting (UK) Limited

Relationship Type

UK Responsible Person

Address

Compass House, Vision Park Histon c/o Cr360 – UL International

Cambridge, England, United Kingdom

Postcode: CB24 9BZ

DJ Fang

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Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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