United Kingdom MHRA device registration 95835

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

United Kingdom·In Vitro Diagnostic Device·Meridian Bioscience Inc.·Registered Nov 26, 2024

Registration details

Device ID: 95835
MHRA Reference Number: 95835
Date Registered: Nov 26, 2024
Last Updated: Sep 10, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD Annex II List B

Manufacturer

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

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 Meridian Bioscience Inc.

Additional devices registered by the same manufacturer

Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)Feb 28, 2025

Type: In Vitro Diagnostic Device

Device ID: 212199

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinicalFeb 28, 2025

Type: In Vitro Diagnostic Device

Device ID: 212198

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

Type: In Vitro Diagnostic Device

Device ID: 95802

Bordetella pertussis nucleic acid IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 95803

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 95811

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 95816

Cryptococcus neoformans antigen IVD, kit, rapid agglutination, clinicalNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 95798

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

Type: In Vitro Diagnostic Device

Device ID: 95806

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 95843

Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 95807

Other products from same authorized representative

Additional devices represented by Launch Diagnostics Limited in the UK

Candida albicans nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 76867

Mumps virus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 150601

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

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 76877

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

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 76863

Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 150597

Parvovirus B19 nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 187898

Streptococcus pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 150599

Nucleic acid extraction/isolation kit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 164946

Treponema pallidum nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 150603

Cardiovascular disease genetic risk IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ

Device ID: 164950

About this record

Cytomegalovirus (CMV) 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 95835. 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device