United Kingdom MHRA device registration 72949

HIV1/HIV2 antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Fujirebio Europe N.V.·Registered Apr 13, 2021
Registration details
Device ID
72949
MHRA Reference Number
72949
Date Registered
Apr 13, 2021
Last Updated
Jan 31, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
HIV1/HIV2 antibody IVD, kit, enzyme immunoassay (EIA)
Type
IVD Annex II List A
Manufacturer
Address
Technologiepark 6
Gent, Oost-Vlaanderen, Belgium
Created Date
Apr 13, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY
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About this record

HIV1/HIV2 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 72949. The device is manufactured by Fujirebio Europe N.V. from Belgium, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

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