BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique - UK MHRA Medical Device Registration
BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 147629. The device is manufactured by 3D Biomedicine Science & Technology Co., Ltd from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology 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
BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Sep 26, 2024
Address
Block A, Building 2, No. 158 Xinjunhuan Rd
Shanghai, China
Created Date
Dec 8, 2021
Relationship Type
Address
Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach
Cambridge, Cambridgeshire, United Kingdom
Postcode: CB25 9QE
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.
Cancer-related multiple gene mutation profile kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Nucleic acid extraction/isolation kit IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Nucleic acid sample preparation instrument IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Human genomic analysis interpretive software IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Pipetting system IVD
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Thermal cycler nucleic acid amplification analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Nucleic acid extraction/isolation kit IVD
Type: In Vitro Diagnostic Device
Manufacturer: Wuxi Techstar Technology Co.,Ltd
Human genomic analysis interpretive software IVD
Type: In Vitro Diagnostic Device
Manufacturer: 3D Biomedicine Science & Technology Co., Ltd
Mycobacterium tuberculosis immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: InnaK Diagnostics, Inc.
Cystatin C IVD, kit, rapid fluorescent immunoassay, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Faecal occult blood IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Multiple lipid analyte IVD, kit, rapid colorimetric, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Pipetting system IVD
Type: In Vitro Diagnostic Device
Manufacturer: 3D Biomedicine Science & Technology Co., Ltd

