United Kingdom MHRA device registration 125286

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Immunalysis Corporation·Registered Nov 26, 2024

Registration details

Device ID: 125286
MHRA Reference Number: 125286
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Immunalysis Corporation
Address: 829 Towne Center Drive
Pomona, California, United States
Created Date: Oct 5, 2021

Authorized Representative

Name: Unipath Limited (trading as Alere International)
Relationship Type: UK Responsible Person
Address: Abbott House Vanwall Road Vanwall Business Park
Maidenhead, Windsor And Maidenhead, England, United Kingdom
Postcode: SL6 4XE

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About this record

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125286. The device is manufactured by Immunalysis Corporation from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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