SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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 90113. The device is manufactured by Aikang Diagnostics Co Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap Ltd.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

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

MHRA Device ID: 90113

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Jul 22, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Aikang Diagnostics Co Ltd.

Address

501 Building 1&3 Hongxin Industrial Park Guanguang Road 1303 Guanlan Longhua District

Guangdong, Shenzhen, China

Created Date

Jul 22, 2021

Authorized Representative

Name

Medimap Ltd

Relationship Type

UK Responsible Person

Address

2 The Drift

Thurston, Suffolk, United Kingdom

Postcode: IP31 3RT

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Aikang Diagnostics Co Ltd. (2)

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

Type: In Vitro Diagnostic Device

Registered: Jul 22, 2021

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

Type: In Vitro Diagnostic Device

Registered: Jul 22, 2021

Other Products from Same Authorized Representative (10)

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

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

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

Vascular catheter introduction needle

Medical equipment drape, single-use

Multiple electrolyte IVD, control

Peripheral intravenous cannula

Patient lifting system bath chair

Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

Handgrip disability-assistive walker, non-powered, foldable

Dental/surgical polymerization lamp

Luer-formatted disinfection cap

Positive-pressure intravenous line needleless valve-connector