SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

SARS-CoV-2 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 165209. The device is manufactured by Mobidiag Oy from Finland, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Hologic Ltd..

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

🇬🇧

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

MHRA Device ID: 165209•Ref: 165209

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Apr 11, 2024

Last Updated

Mar 12, 2024

Manufacturer Information

Name

Mobidiag Oy

Address

Keilaranta 16A

Espoo, Finland

Created Date

Jan 20, 2023

Authorized Representative

Name

Hologic Ltd.

Relationship Type

UK Responsible Person

Address

Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester, Lancashire, England, United Kingdom

Postcode: M23 9HZ

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Mobidiag Oy (10)

Other Products from Same Authorized Representative (10)

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

General specimen container IVD, additive/medium

Multiple-type gastrointestinal pathogen nucleic acid IVD, calibrator

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

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Clostridium difficile nucleic acid IVD, calibrator

Laboratory instrument/analyser application software IVD

Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

Multiple gastrointestinal disease-associated bacteria nucleic acid IVD, calibrator

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

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

Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)

Cytomegalovirus (CMV) nucleic acid IVD, reagent

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Buffered sample diluent IVD, automated/semi-automated system

Cytomegalovirus (CMV) nucleic acid IVD, control

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Fibronectin IVD, kit, enzyme immunohistochemistry