United Kingdom MHRA device registration 76459

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

United Kingdom·In Vitro Diagnostic Device·Wuhan Life Origin Biotech Joint Stock Co., Ltd·Registered Apr 27, 2021

Registration details

Device ID: 76459
MHRA Reference Number: 76459
Date Registered: Apr 27, 2021
Last Updated: Jan 13, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Wuhan Life Origin Biotech Joint Stock Co., Ltd
Address: Floor 1st, 2nd and 3rd, Wuhan Hi-Tech Medical Device Park B11,No.818 Gaoxin Avenue, Donghu Hi-Tech Development Zone,
Wuhan, Hubei Province,, China
Created Date: Apr 27, 2021

Authorized Representative

Name: NPZ technology Ltd
Relationship Type: UK Responsible Person
Address: Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach
Cambridge, Cambridgeshire, United Kingdom
Postcode: CB25 9QE

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About this record

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 76459. The device is manufactured by Wuhan Life Origin Biotech Joint Stock Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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