Laboratory instrument/analyser application software IVD - UK MHRA Medical Device Registration
Laboratory instrument/analyser application software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125930. The device is manufactured by Fujirebio Europe N.V. from Belgium, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK 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
Laboratory instrument/analyser application software IVD
Type
Class A
Date Registered
Nov 26, 2024
Last Updated
May 9, 2024
Address
Technologiepark 6
Gent, Oost-Vlaanderen, Belgium
Created Date
Apr 13, 2021
Name
Qarad UK Ltd.Relationship Type
Address
8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY
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
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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.
Tau protein IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Digital imaging scanner/reader calibration card IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human placental alkaline phosphatase (hPLAP) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Laboratory instrument/analyser application software IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Line probe assay interpretation template IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Tau protein IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Faecal occult blood IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Glomerular basement membrane antibody (Goodpasture antibody) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Multiple antinuclear antibody (ANA) screening IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Multiple antinuclear antibody (ANA) screening IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Multiple clinical chemistry analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.
Endomysium antibody (EMA) IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: BIOSYSTEMS S.A.

