Multiplex analyser IVD, laboratory - UK MHRA Medical Device Registration

Multiplex analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 189736. The device is manufactured by Luminex Corporation 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 Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Multiplex analyser IVD, laboratory

MHRA Device ID: 189736•Ref: 189736

Device Type

In Vitro Diagnostic Device

Devices

Multiplex analyser IVD, laboratory

Type

Class A

Date Registered

Nov 26, 2024

Last Updated

Jul 6, 2024

Manufacturer Information

Name

Luminex Corporation

Address

12212 Technology Blvd

Austin, Texas, United States

Created Date

Dec 23, 2021

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

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Luminex Corporation (10)

Other Products from Same Authorized Representative (10)

Multiplex analyser IVD, laboratory - 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

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

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Cystic fibrosis IVD, kit, multiplex

Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Laboratory instrument/analyser application software IVD

Laboratory instrument/analyser application software IVD

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Bartonella bacilliformis immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Assay adhesive sealing/fixation film IVD

Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD, reagent

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, reagent

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Aldosterone IVD, control

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, control

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, reagent