HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing - UK MHRA Medical Device Registration

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 175800. The device is manufactured by Abbott Rapid Diagnostics Jena GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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In Vitro Diagnostic Device

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HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

MHRA Device ID: 175800•Ref: 175800

Device Type

In Vitro Diagnostic Device

Devices

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Type

IVD Annex II List A

Date Registered

Nov 26, 2024

Last Updated

Nov 15, 2024

Manufacturer Information

Name

Abbott Rapid Diagnostics Jena GmbH

Address

Orlaweg 1

Jena, Thuringia, Germany

Created Date

Mar 15, 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

DJ Fang

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HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing - UK MHRA Medical Device Registration

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