Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 213647. The device is manufactured by DiaSorin Molecular LLC from United States, classified as In Vitro Diagnostic Device.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, 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

🇬🇧

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 213647

Device Type

In Vitro Diagnostic Device

Type

Class C

Status

DREGIY

Date Registered

Mar 19, 2025

Manufacturer Information

Name

DiaSorin Molecular LLC

Address

11331 Valley View St.

Cypress, California, United States

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from DiaSorin Molecular LLC (10)

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Device Type

Type

Status

Date Registered

Name

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

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, reagent

Bartonella bacilliformis immunoglobulin G (IgG) antibody IVD, reagent

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

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Assay adhesive sealing/fixation film IVD

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

Coxiella burnetii immunoglobulin G (IgG) antibody IVD, reagent

Anaplasma phagocytophilum immunoglobulin G (IgG) antibody IVD, control