Echovirus immunoglobulin M (IgM) antibody (serotypes EV1-EV33) IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Echovirus immunoglobulin M (IgM) antibody (serotypes EV1-EV33) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 88535. The device is manufactured by Virion\Serion GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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Echovirus immunoglobulin M (IgM) antibody (serotypes EV1-EV33) IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 88535•Ref: 88535

Device Type

In Vitro Diagnostic Device

Devices

Echovirus immunoglobulin M (IgM) antibody (serotypes EV1-EV33) IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Jul 12, 2021

Last Updated

Oct 13, 2022

Manufacturer Information

Name

Virion\Serion GmbH

Address

Friedrich-Bergius-Ring 19

Wurzburg, Germany

Created Date

Jul 12, 2021

Authorized Representative

Name

Launch Diagnostics Limited

Relationship Type

UK Responsible Person

Address

Ash House Ash Road New Ash Green

Longfield, Kent, United Kingdom

Postcode: DA3 8JD

DJ Fang

MedTech Regulatory Expert

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Echovirus immunoglobulin M (IgM) antibody (serotypes EV1-EV33) IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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