United Kingdom MHRA device registration 165276

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

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Uniogen Oy·Registered Nov 26, 2024
Registration details
Device ID
165276
MHRA Reference Number
165276
Date Registered
Nov 26, 2024
Last Updated
Apr 5, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Type
IVD General
Manufacturer
Address
Tykistökatu 4
Turku, Finland
Created Date
Jan 23, 2023
Authorized Representative
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 Uniogen Oy

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by Launch Diagnostics Limited in the UK

Cardiovascular disease genetic risk IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Clonit Srl
Device ID: 115281
Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Clonit Srl
Device ID: 115242
Streptococcus pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Uniogen Oy
Device ID: 165280
Ankylosing spondylitis IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Clonit Srl
Device ID: 115245
Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: IVD Research Inc.
Device ID: 77177
Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: IVD Research Inc.
Device ID: 77174
Multiple faecal parasite antigen IVD, kit, rapid ICT, clinicalNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Operon S.A.
Device ID: 195178
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Uniogen Oy
Device ID: 165277
Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Clonit Srl
Device ID: 115252
Coeliac disease genetic risk factor IVD, kit, nucleic acid technique (NAT)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Clonit Srl
Device ID: 115246
About this record

Clostridium difficile 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 165276. The device is manufactured by Uniogen Oy from Finland, 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