United Kingdom MHRA device registration 83195

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

United Kingdom·In Vitro Diagnostic Device·Hangzhou Alltest Biotech Co Ltd·Registered Nov 26, 2024

Registration details

Device ID: 83195
MHRA Reference Number: 83195
Date Registered: Nov 26, 2024
Last Updated: Jun 15, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Type: IVD General

Manufacturer

Name: Hangzhou Alltest Biotech Co Ltd
Address: #550 Yinhai Street Hangzhou Economic & Technological Development Area
Hangzhou, China
Created Date: Mar 9, 2021

Authorized Representative

Name: Medimap Ltd
Relationship Type: UK Responsible Person
Address: 2 The Drift
Thurston, Suffolk, United Kingdom
Postcode: IP31 3RT

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About this record

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 83195. The device is manufactured by Hangzhou Alltest Biotech Co Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap Ltd.

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