United Kingdom MHRA device registration 191773

Cystic fibrosis IVD, kit, multiplex

United Kingdom·In Vitro Diagnostic Device·Luminex Molecular Diagnostics, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 191773
MHRA Reference Number: 191773
Date Registered: Nov 26, 2024
Last Updated: Apr 17, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cystic fibrosis IVD, kit, multiplex
Type: IVD General

Manufacturer

Name: Luminex Molecular Diagnostics, Inc.
Address: 439 University Ave
Toronto, Ontario, Canada
Created Date: Apr 15, 2024

Authorized Representative

Name: DiaSorin Italia S.p.A. UK Branch
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 Luminex Molecular Diagnostics, Inc.

Additional devices registered by the same manufacturer

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 191518

Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplexNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 191774

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 191521

Other products from same authorized representative

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

Bartonella bacilliformis immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120851

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120745

Assay adhesive sealing/fixation film IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 196522

Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120852

Beta-haemolytic Group B Streptococcus nucleic acid IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120756

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120849

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120858

Aldosterone IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Inc.

Device ID: 122668

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120855

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: DiaSorin Molecular LLC

Device ID: 120846

About this record

Cystic fibrosis IVD, kit, multiplex is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 191773. The device is manufactured by Luminex Molecular Diagnostics, Inc. from Canada, 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