Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 148496. The device is manufactured by Shanghai Homelabs Medical 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
Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay
Type
IVD General
Date Registered
Nov 26, 2024
Last Updated
Jan 13, 2024
Address
Room 301, No. 5, Lane 88, Shengrong Road, China (Shanghai) Pilot Free Trade Zone.
Shanghai , China
Created Date
May 25, 2022
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.
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
D-dimer IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Glycated haemoglobin (HbA1c) IVD, kit, fluorescent immunoassay, rapid
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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
Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Pressure bandage, non-latex, single-use
Type: General Medical Device
Manufacturer: Hangzhou Yoniner Pharmaceutical Co., Ltd
Basic intravenous administration set, noninvasive
Type: General Medical Device
Manufacturer: Hanscent ๏ผNingbo๏ผ Co., Ltd.
Electronic gravity infusion controller administration set
Type: General Medical Device
Manufacturer: Hanscent ๏ผNingbo๏ผ Co., Ltd.
Analgesic transcutaneous electrical nerve stimulation system
Type: General Medical Device
Manufacturer: Cathay Manufacturing Corp
Alpha-fetoprotein (AFP) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Microalbumin IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Shanghai Homelabs Medical Co., Ltd
Limb immobilization/support skin adhesive tape
Type: General Medical Device
Manufacturer: Hangzhou Yoniner Pharmaceutical Co., Ltd

