United Kingdom MHRA device registration 86804

Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

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

Registration details

Device ID: 86804
MHRA Reference Number: 86804
Date Registered: Nov 26, 2024
Last Updated: Nov 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

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

Multiple Leptospira species immunoglobulin M (IgM) 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 86804. 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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