Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Aspergillus fumigatus immunoglobulin G (IgG) 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 119126. The device is manufactured by Dynamiker Biotechnology (Tianjin) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

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Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 119126•Ref: 119126

Device Type

In Vitro Diagnostic Device

Devices

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Sep 25, 2024

Manufacturer Information

Name

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Address

No.2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA,

Tianjin, China

Created Date

Dec 10, 2021

Authorized Representative

Name

Wellkang Ltd

Relationship Type

UK Responsible Person

Address

16 Castle St.

Dover, Kent, England, United Kingdom

Postcode: CT16 1PW

DJ Fang

MedTech Regulatory Expert

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Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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