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

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 92409. The device is manufactured by Zhejiang Quark Biological Technology Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

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

MHRA Device ID: 92409•Ref: 92409

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Aug 25, 2024

Last Updated

Oct 17, 2023

Manufacturer Information

Name

Zhejiang Quark Biological Technology Co., Ltd.

Address

No.1 Jiangdong Road, Zhejiang Xinchang High-tech Industrial Park,

Shaoxing Xinchang District, Zhejiang , China

Created Date

Dec 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

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

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Address

DJ Fang

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