SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
SARS-CoV-2 immunoglobulin G (IgG)/IgM 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 76459. The device is manufactured by Wuhan Life Origin Biotech Joint Stock 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
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type
IVD General
Date Registered
Apr 27, 2021
Last Updated
Jan 13, 2024
Address
Floor 1st, 2nd and 3rd, Wuhan Hi-Tech Medical Device Park B11,No.818 Gaoxin Avenue, Donghu Hi-Tech Development Zone,
Wuhan, Hubei Province,, China
Created Date
Apr 27, 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.
SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Registered: Apr 27, 2021
SARS-CoV-2 neutralizing antibody IVD, kit, fluorescent immunoassay, rapid
Type: In Vitro Diagnostic Device
Registered: Apr 27, 2021
Fluorescent immunoassay analyser IVD, point-of-care, battery-powered
Type: In Vitro Diagnostic Device
Registered: Apr 27, 2021
Dressing-fixation skin adhesive tape, non-silicone
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Exudate-absorbent dressing, non-gel, non-antimicrobial
Type: General Medical Device
Manufacturer: Changzhou Major Medical Products Co., LTD
Endodontic obturation system
Type: General Medical Device
Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,
Head-worn lamp
Type: General Medical Device
Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,
Surgical binoculars, reusable
Type: General Medical Device
Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.,
Dermatological frequency-doubled solid-state laser system
Type: General Medical Device
Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.
General/multiple surgical carbon dioxide laser system
Type: General Medical Device
Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.
Surgical instrument/endoscope cleaning utensil, single-use
Type: General Medical Device
Manufacturer: Changzhou Health Microport Medical Device Co., Ltd.

