Inherited haemoglobinopathy IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration
Inherited haemoglobinopathy 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 160923. The device is manufactured by ViennaLab Diagnostics GmbH from Austria, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Oxford Biosystems 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
Inherited haemoglobinopathy IVD, kit, nucleic acid technique (NAT)
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Mar 6, 2024
Address
Gaudenzdorfer Guertel 43-45
Vienna, Austria
Created Date
Jul 8, 2022
Relationship Type
Address
184B Park Drive Milton Park Abingdon
Abingdon, Oxfordshire, United Kingdom
Postcode: OX14 4SE
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.
Coagulation factor XII mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 22, 2025
Cytochrome P450 (CYP450) gene polymorphism IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 22, 2025
HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 22, 2025
Coagulation factor XIII mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 22, 2025
Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Mar 22, 2025
Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
KRAS gene mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
NRAS gene mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Pseudomonas aeruginosa immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: Mediagnost GmbH
Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Borrelia afzelii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Borrelia burgdorferi total antibody IVD, kit, immunoblot
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Chlamydia pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Laboratory instrument/analyser application software IVD
Type: In Vitro Diagnostic Device
Manufacturer: Advanced Imaging Devices GmbH

