Coxiella burnetii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Coxiella burnetii 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 189488. 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.

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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Coxiella burnetii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 189488•Ref: 189488

Device Type

In Vitro Diagnostic Device

Devices

Coxiella burnetii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Aug 21, 2024

Manufacturer Information

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

DJ Fang

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Coxiella burnetii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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