United Kingdom MHRA device registration 58402

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

United Kingdom·In Vitro Diagnostic Device·Xiamen Boson Biotech Co., Ltd.·Registered Nov 19, 2024

Registration details

Device ID: 58402
MHRA Reference Number: 58402
Date Registered: Nov 19, 2024
Last Updated: Mar 28, 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: Xiamen Boson Biotech Co., Ltd.
Address: 90-94 Tianfeng Road, Jimei North Industrial Park
Xiamen, Fujian , China
Created Date: Nov 2, 2020

Authorized Representative

Name: lotus global co ltd
Relationship Type: UK Responsible Person
Address: 23 Maine Street
Reading, Reading, England, United Kingdom
Postcode: RG2 6AG

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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 58402. The device is manufactured by Xiamen Boson Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is lotus global co ltd.

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