SARS-CoV-2 total antibody IVD, kit, magnetic immunoassay, rapid - UK MHRA Medical Device Registration

SARS-CoV-2 total antibody IVD, kit, magnetic immunoassay, rapid is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 109899. The device is manufactured by Blusense Diagnostics ApS from Denmark, 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 total antibody IVD, kit, magnetic immunoassay, rapid

MHRA Device ID: 109899

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 total antibody IVD, kit, magnetic immunoassay, rapid

Type

IVD General

Date Registered

Oct 26, 2021

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Blusense Diagnostics ApS

Address

Fruebjergvej 3

Copenhagen, Denmark

Created Date

Oct 26, 2021

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 Blusense Diagnostics ApS (1)

Multiplex analyser IVD, point-of-care

Type: In Vitro Diagnostic Device

Registered: Oct 26, 2021

Other Products from Same Authorized Representative (10)

SARS-CoV-2 total antibody IVD, kit, magnetic immunoassay, rapid - 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

Multiplex analyser IVD, point-of-care

Calprotectin IVD, kit, rapid ICT, clinical

Optical laboratory instrument performance standard calibrator/control IVD, single-use

HIV1/HIV2 antibody IVD, control

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Oral/upper respiratory tract specimen collection kit

Oral/upper respiratory tract specimen collection kit IVD, clinical

Carpal scaphoid prosthesis

Fluted surgical drill bit, reusable

Specimen information management system IVD