United Kingdom MHRA device registration 72545

Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·bioMérieux S.A·Registered Nov 26, 2024

Registration details

Device ID: 72545
MHRA Reference Number: 72545
Date Registered: Nov 26, 2024
Last Updated: May 17, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD Annex II List A

Manufacturer

Name: bioMérieux S.A
Address: bioMérieux S.A
Marcy L'Etoile (69280), France
Created Date: Mar 30, 2021

Authorized Representative

Name: bioMérieux UK Ltd
Relationship Type: UK Responsible Person
Address: Chineham Gate Crockford Lane
Basingstoke, Hampshire, England, United Kingdom
Postcode: RG24 8NA

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About this record

Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 72545. The device is manufactured by bioMérieux S.A from France, classified as In Vitro Diagnostic Device. The authorized representative in the UK is bioMérieux UK Ltd.

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