Fluorescent immunoassay analyser IVD, point-of-care - UK MHRA Medical Device Registration
Fluorescent immunoassay analyser IVD, point-of-care is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 178446. The device is manufactured by 77 Elektronika Kft. from Hungary, classified as In Vitro Diagnostic Device. The authorized representative in the UK is A. Menarini Diagnostics 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.
Device Type
In Vitro Diagnostic Device
Devices
Fluorescent immunoassay analyser IVD, point-of-care
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
Nov 15, 2023
Address
H-1116 Budapest Fehรฉrvรกri รบt 98
Budapest, Hungary
Created Date
Dec 22, 2021
Relationship Type
Address
405 Wharfedale Road
Wokingham, Berkshire, England, United Kingdom
Postcode: RG41 5RA
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Cryptosporidium species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
D-dimer IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
C-reactive protein (CRP) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Troponin I IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Urine analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Urine analyser IVD, laboratory, semi-automated
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
D-dimer IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Laboratory analyser cuvette IVD, single-use
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Laboratory analyser cuvette IVD, single-use
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Urine analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Glycated haemoglobin (HbA1c) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: 77 Elektronika Kft.
Human chorionic gonadotropin beta-core fragment IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: 77 Elektronika Kft.
Microalbumin IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: 77 Elektronika Kft.
Isothermal nucleic acid amplification analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Manufacturer: Curetis GmbH
Multiple tissue pathogenic bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Curetis GmbH
Multiple urinary tract pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Curetis GmbH
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Curetis GmbH
Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: DIA.PRO Diagnostic Bioprobes S.r.l.
Hepatitis E virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: DIA.PRO Diagnostic Bioprobes S.r.l.
Fluorescent immunoassay analyser IVD, point-of-care, line-powered
Type: In Vitro Diagnostic Device
Manufacturer: 77 Elektronika Kft.

