United Kingdom MHRA device registration 148503

Mycobacterium tuberculosis immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

United Kingdom·In Vitro Diagnostic Device·Shanghai Homelabs Medical Co., Ltd·Registered Nov 26, 2024

Registration details

Device ID: 148503
MHRA Reference Number: 148503
Date Registered: Nov 26, 2024
Last Updated: Jan 13, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Mycobacterium tuberculosis immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: IVD General

Manufacturer

Name: Shanghai Homelabs Medical Co., Ltd
Address: Room 301, No. 5, Lane 88, Shengrong Road, China (Shanghai) Pilot Free Trade Zone.
Shanghai , China
Created Date: May 25, 2022

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

Mycobacterium tuberculosis 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 148503. The device is manufactured by Shanghai Homelabs Medical Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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