United Kingdom MHRA device registration 73843

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

United Kingdom·In Vitro Diagnostic Device·Abbott Diagnostics Medical Co., Ltd.·Registered Apr 18, 2021

Registration details

Device ID: 73843
MHRA Reference Number: 73843
Date Registered: Apr 18, 2021
Last Updated: Apr 4, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Type: IVD Annex II List A

Manufacturer

Name: Abbott Diagnostics Medical Co., Ltd.
Address: 357 Matsuhidai Matsudo-shi
Chiba, Japan
Created Date: Apr 18, 2021

Authorized Representative

Name: Unipath Limited (trading as Alere International)
Relationship Type: UK Responsible Person
Address: Clearblue Innovation Centre Priory Business Park Stannard Way
Bedford, Bedfordshire, England, United Kingdom
Postcode: MK44 3UP

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About this record

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 73843. The device is manufactured by Abbott Diagnostics Medical Co., Ltd. from Japan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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