United Kingdom MHRA device registration 122699

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·DiaSorin Inc.·Registered Nov 26, 2024
Registration details
Device ID
122699
MHRA Reference Number
122699
Date Registered
Nov 26, 2024
Last Updated
Jun 7, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
Type
IVD General
Manufacturer
Address
1951 Northwestern Avenue
Stillwater, MN, United States
Created Date
Dec 16, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
Central Road
Dartford, England, United Kingdom
Postcode: DA1 5LR
Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176179
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176185
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175386
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176184
C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176164
Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176139
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175389
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175394
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Device ID: 175395
D-dimer IVD, kit, fluorescent immunoassayN/A
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Device ID: 176162
Other products from DiaSorin Inc.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by DiaSorin Italia S.p.A. UK Branch in the UK

C-peptide IVD, kit, chemiluminescent immunoassayNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 122011
Chemiluminescent immunoassay analyser IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 166457
Chemiluminescent immunoassay oxidizing reagent IVDNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 166470
Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 76493
Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 76494
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 76496
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 76499
Double stranded DNA antibody (anti-dsDNA) IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 121706
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 121707
Bordetella pertussis immunoglobulin A (IgA) antibody IVD, controlNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: DiaSorin Italia S.p.A.
Device ID: 197437
About this record

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 122699. The device is manufactured by DiaSorin Inc. from United States, 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.

Free DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device