United Kingdom MHRA device registration 83416

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Beijing BGI-GBI Biotech Co., Ltd. ·Registered Nov 26, 2024

Registration details

Device ID: 83416
MHRA Reference Number: 83416
Date Registered: Nov 26, 2024
Last Updated: Apr 3, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Beijing BGI-GBI Biotech Co., Ltd.
Address: Building 1-236, 237, No.538 Yongfeng Tun, Haidian District
Beijing, China
Created Date: May 28, 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 neutralizing 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 83416. The device is manufactured by Beijing BGI-GBI Biotech Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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