Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration
Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 76475. The device is manufactured by DiaSorin Italia S.p.A. from Italy, classified as In Vitro Diagnostic Device. The authorized representative in the UK is DiaSorin Italia S.p.A. UK Branch.
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.
Device Type
In Vitro Diagnostic Device
Devices
Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Type
IVD Annex II List A
Date Registered
Nov 26, 2024
Last Updated
Jun 7, 2024
Address
DiaSorin Italia S.p.A. Via Crescentino SALUGGIA
VC, Piemonte, Italy
Created Date
Apr 27, 2021
Relationship Type
Address
Central Road
Dartford, England, United Kingdom
Postcode: DA1 5LR
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Legionella pneumophila antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Mar 18, 2025
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Mar 18, 2025
Multiple Borrelia species immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Mar 18, 2025
Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Mar 18, 2025
Hepatitis B virus e-antigen IVD, control
Type: In Vitro Diagnostic Device
Registered: Feb 6, 2025
Trypanosoma cruzi total antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Feb 6, 2025
Trypanosoma cruzi total antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Feb 6, 2025
Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Feb 6, 2025
Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cystic fibrosis IVD, kit, multiplex
Type: In Vitro Diagnostic Device
Manufacturer: Luminex Corporation
Multiplex analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Manufacturer: Luminex Corporation
Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Luminex Corporation
Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Neuron-specific enolase (NSE) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Neuron-specific enolase (NSE) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Parvovirus B19 immunoglobulin M (IgM) antibody IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Luminex Corporation

