United Kingdom MHRA device registration 142739

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Mikrogen GmbH·Registered Nov 26, 2024

Registration details

Device ID: 142739
MHRA Reference Number: 142739
Date Registered: Nov 26, 2024
Last Updated: Sep 20, 2024

Device classification

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

Manufacturer

Name: Mikrogen GmbH
Address: Anna-Sigmund-Str 10 Neuried
München, Oberbayern, Germany
Created Date: Mar 31, 2022

Authorized Representative

Name: IVDeology UKRP Ltd
Relationship Type: UK Responsible Person
Address: Maidstone Innovation Centre Gidds Pond Way
Maidstone, Kent, England, United Kingdom
Postcode: ME14 5FY

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About this record

Treponema pallidum 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 142739. The device is manufactured by Mikrogen GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is IVDeology UKRP Ltd.

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