United Kingdom MHRA device registration 180041

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

United Kingdom·In Vitro Diagnostic Device·Abbott Diagnostics Medical Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 180041
MHRA Reference Number: 180041
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical
Type: Class D – Self-testing or Near-patient Testing

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: Abbott House Vanwall Road Vanwall Business Park
Maidenhead, Windsor And Maidenhead, England, United Kingdom
Postcode: SL6 4XE

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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 180041. 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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