HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 192217. The device is manufactured by Abbott Diagnostics Medical Co., Ltd. from Japan, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Unipath Limited (trading as Alere International).
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
HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
Type
Class D
Date Registered
Nov 26, 2024
Last Updated
Nov 15, 2024
Address
357 Matsuhidai Matsudo-shi
Chiba, Japan
Created Date
Apr 18, 2021
Relationship Type
Address
Abbott House Vanwall Road Vanwall Business Park
Maidenhead, Windsor And Maidenhead, England, United Kingdom
Postcode: SL6 4XE
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.
Buffered isotonic saline reagent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Treponema pallidum total antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Buffered isotonic saline reagent IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Capillary blood collection tube IVD, K2EDTA
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Capillary blood collection tube IVD, K2EDTA
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
HIV1/HIV2 antigen/antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
HIV1/HIV2 antigen/antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Treponema pallidum total antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Multiple lipid analyte IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Technologies AS
Single-channel clinical chemistry analyser IVD, point-of-care
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Technologies AS
Single-channel clinical chemistry analyser IVD, point-of-care
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Technologies AS
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Scarborough, Inc.
General specimen collection kit IVD, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Isothermal nucleic acid amplification analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Scarborough, Inc.
Legionella pneumophila antigen IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Scarborough, Inc.
HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Abbott Diagnostics Medical Co., Ltd.

