SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay, rapid - UK MHRA Medical Device Registration

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay, rapid is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 146132. The device is manufactured by NewScen Coast Bio-Pharmaceutical Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

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In Vitro Diagnostic Device

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SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay, rapid

MHRA Device ID: 146132•Ref: 146132

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay, rapid

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

May 26, 2024

Manufacturer Information

Name

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Address

No. 65, 6th Street, Tianjin TEDA,

Tianjin, China

Created Date

Sep 18, 2020

Authorized Representative

Name

Wellkang Ltd

Relationship Type

Authorised Representative (Northern Ireland)

Address

Enterprise Hub, NW Business Complex 1 Beraghmore Road

Derry, Northern Ireland, Northern Ireland, United Kingdom

Postcode: BT48 8SE

DJ Fang

MedTech Regulatory Expert

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SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay, rapid - UK MHRA Medical Device Registration

Device Type

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Created Date

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Address

DJ Fang

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