United Kingdom MHRA device registration 76471

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

United Kingdom·In Vitro Diagnostic Device·DiaSorin Italia S.p.A. ·Registered Nov 26, 2024

Registration details

Device ID: 76471
MHRA Reference Number: 76471
Date Registered: Nov 26, 2024
Last Updated: Jun 7, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Type: IVD Annex II List A

Manufacturer

Name: DiaSorin Italia S.p.A.
Address: DiaSorin Italia S.p.A. Via Crescentino SALUGGIA
VC, Piemonte, Italy
Created Date: Apr 27, 2021

Authorized Representative

Name: DiaSorin Italia S.p.A. UK Branch
Relationship Type: UK Responsible Person
Address: Central Road
Dartford, England, United Kingdom
Postcode: DA1 5LR

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About this record

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 76471. The device is manufactured by DiaSorin Italia S.p.A. from Italy, classified as In Vitro Diagnostic Device. The authorized representative in the UK is DiaSorin Italia S.p.A. UK Branch.

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