United Kingdom MHRA device registration 73844

Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical

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

Registration details

Device ID: 73844
MHRA Reference Number: 73844
Date Registered: Apr 18, 2021
Last Updated: Apr 4, 2023

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical
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

Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 73844. 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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