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

Dengue virus 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 162092. The device is manufactured by Jiangsu KeyGEN BioTECH Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is HUMISS COMPANY LIMITED.

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Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

MHRA Device ID: 162092•Ref: 162092

Device Type

In Vitro Diagnostic Device

Devices

Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Dec 1, 2022

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Jiangsu KeyGEN BioTECH Co., Ltd.

Address

Building 6, No.18 Zhilan Road, Jiangning Science Park, Jiangning District

Nanjing City, Jiangsu Province, China

Created Date

Dec 1, 2022

Authorized Representative

Name

HUMISS COMPANY LIMITED

Relationship Type

UK Responsible Person

Address

Suite 145 82-84 Bell Yard

London, England, United Kingdom

Postcode: WC2A 2JR

DJ Fang

MedTech Regulatory Expert

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

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