Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Respiratory syncytial virus (RSV) 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 189446. 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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In Vitro Diagnostic Device

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Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 189446•Ref: 189446

Device Type

In Vitro Diagnostic Device

Devices

Respiratory syncytial virus (RSV) 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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Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Device Type

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Last Updated

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Created Date

Name

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Address

DJ Fang

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