United Kingdom MHRA device registration 71195

HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Abbott Diagnostics Korea, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 71195
MHRA Reference Number: 71195
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical
Type: IVD Annex II List A

Manufacturer

Name: Abbott Diagnostics Korea, Inc.
Address: 65 Borahagal-Ro Giheung-Gu
Gyeonggi-Do, Yongin-Si, South Korea
Created Date: Mar 30, 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

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About this record

HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 71195. The device is manufactured by Abbott Diagnostics Korea, Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).

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