Zika virus antigen IVD, kit, fluorescent immunoassay, rapid - UK MHRA Medical Device Registration

Zika virus antigen IVD, kit, fluorescent immunoassay, rapid is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 131402. The device is manufactured by SD Biosensor, Inc. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting Ltd.

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In Vitro Diagnostic Device

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Zika virus antigen IVD, kit, fluorescent immunoassay, rapid

MHRA Device ID: 131402•Ref: 131402

Device Type

In Vitro Diagnostic Device

Devices

Zika virus antigen IVD, kit, fluorescent immunoassay, rapid

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jun 22, 2024

Manufacturer Information

Name

SD Biosensor, Inc.

Address

C-4th&5th, 16 Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, Republic of Korea

Suwon-si, South Korea

Created Date

May 11, 2021

Authorized Representative

Name

MT Promedt Consulting Ltd

Relationship Type

UK Responsible Person

Address

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

DJ Fang

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Zika virus antigen IVD, kit, fluorescent immunoassay, rapid - UK MHRA Medical Device Registration

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