Nucleic acid extraction/isolation kit IVD - UK MHRA Medical Device Registration

Nucleic acid extraction/isolation kit IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 95837. The device is manufactured by Meridian Bioscience Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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

🇬🇧

Nucleic acid extraction/isolation kit IVD

MHRA Device ID: 95837•Ref: 95837

Device Type

In Vitro Diagnostic Device

Devices

Nucleic acid extraction/isolation kit IVD

Type

IVD Annex II List B

Date Registered

Nov 26, 2024

Last Updated

Sep 10, 2024

Manufacturer Information

Name

Meridian Bioscience Inc.

Address

3471 River Hills Drive

Cincinnati, OH, United States

Created Date

Aug 18, 2021

Authorized Representative

Name

Launch Diagnostics Limited

Relationship Type

UK Responsible Person

Address

Unit 20 Ash Way Thorp Arch Estate

Wetherby, England, United Kingdom

Postcode: LS23 7FA

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Meridian Bioscience Inc. (10)

Other Products from Same Authorized Representative (10)

Nucleic acid extraction/isolation kit IVD - 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 Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

Bordetella pertussis nucleic acid IVD, control

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinical

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

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

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

Blood cell lysis reagent IVD

Giardia lamblia antigen IVD, control

Differential/selective broth culture medium IVD

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Negative control immunoglobulin IVD

Rotavirus antigen IVD, kit, rapid ICT, clinical

Helicobacter pylori antigen IVD, control

Treponema pallidum reagin antibody IVD, kit, agglutination

Ankylosing spondylitis IVD, kit, nucleic acid technique (NAT)