United Kingdom MHRA device registration 189436

Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Gold Standard Diagnostics Frankfurt GmbH·Registered Nov 26, 2024

Registration details

Device ID: 189436
MHRA Reference Number: 189436
Date Registered: Nov 26, 2024
Last Updated: Aug 21, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Gold Standard Diagnostics Frankfurt GmbH
Address: Waldstrasse 23 A6
Dietzenbach, Germany
Created Date: Dec 30, 2021

Authorized Representative

Name: Werfen Ltd
Relationship Type: UK Responsible Person
Address: 712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE

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About this record

Tick-borne encephalitis (TBE) virus 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 189436. The device is manufactured by Gold Standard Diagnostics Frankfurt GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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