SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 175577. The device is manufactured by Shenzhen Tisenc Medical Devices Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK 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, chemiluminescent immunoassay

MHRA Device ID: 175577•Ref: 175577

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay

Type

IVD General

Date Registered

Apr 11, 2024

Last Updated

Mar 2, 2024

Manufacturer Information

Name

Shenzhen Tisenc Medical Devices Co., Ltd.

Address

11F, 11G, Kechuang Building Quanzhi Science and Innovation Park Maozhoushan Industrial Park Shajing Community,

Shenzhen, BaoAn District, China

Created Date

Sep 2, 2022

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Shenzhen Tisenc Medical Devices Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay - 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

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

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

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Dengue virus antigen IVD, kit, chemiluminescent immunoassay

Dengue virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Lipoprotein-associated phospholipase A2 (Lp-PLA2) IVD, kit, chemiluminescent immunoassay

Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Chemiluminescent immunoassay analyser IVD

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Vaginal pH screening IVD, kit, rapid colorimetric, self-testing

C-reactive protein (CRP) IVD, kit, rapid ICT, clinical

Gliadin antibody IVD, kit, rapid ICT, self-testing

Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical

Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testing

Amniotic fluid leak detection device IVD

Ferritin IVD, kit, rapid ICT, self-testing

Buffered sample diluent IVD