Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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

MHRA Device ID: 73844•Ref: 73844

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD Annex II List A

Date Registered

Apr 18, 2021

Last Updated

Apr 4, 2023

Manufacturer Information

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

DJ Fang

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Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

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

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