SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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 98780. The device is manufactured by DxGen Corp. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

MHRA Device ID: 98780•Ref: 98780

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Aug 25, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

Name

DxGen Corp.

Address

Rm. 303-1 and Rm. 510, 172 LS-ro

Gunpo-si, Gyeonggi-do, South Korea

Created Date

Aug 25, 2021

Authorized Representative

Name

MT Promedt Consulting Ltd

Relationship Type

UK Responsible Person

Address

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from DxGen Corp. (1)

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

Type: In Vitro Diagnostic Device

Registered: Aug 25, 2021

Other Products from Same Authorized Representative (10)

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

Laparoscopic motorized instrument control unit

Multiple Candida species nucleic acid IVD, kit, nucleic acid technique (NAT)

Mycobacterium tuberculosis complex species nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Adenovirus antigen IVD, kit, fluorescent immunoassay

Albumin IVD, kit, fluorescent immunoassay

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)