Proprotein convertase subtilisin/kexin type 9 (PCSK9) IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration
Proprotein convertase subtilisin/kexin type 9 (PCSK9) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 159484. The device is manufactured by Biovendor - Laboratorni medicina a.s. from Czechia, 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
Proprotein convertase subtilisin/kexin type 9 (PCSK9) IVD, kit, enzyme immunoassay (EIA)
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Sep 11, 2024
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.
Prostate secretory protein 94 (PSP94) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Resistin/adipose tissue-specific secretory factor (ADSF) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Clara cell protein IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Interleukin-6 (IL-6) IVD, kit, multiplex
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Tumour necrosis factor receptor superfamily IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cartilage oligomeric matrix protein (COMP) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Corticosteroid-binding globulin (CBG) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Isocitrate dehydrogenase 1/isocitrate dehydrogenase 2 (IDH1/IDH2) gene mutation IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Leptin receptor IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Adenovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Borrelia afzelii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Borrelia garinii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Influenza A virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o
Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: TestLine Clinical Diagnostics s.r.o

