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 151298. The device is manufactured by Asan Pharmaceutical Co., Ltd. from South Korea, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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
Nov 26, 2024
Last Updated
Oct 5, 2023
Address
122-26, Gieopdanji-ro, Gongdo-eup
Anseong-si, Gyeonggi-do, South Korea
Created Date
Jul 7, 2022
Relationship Type
Address
Beaver House, 23-38 Hythe Bridge Street
Oxford, England, United Kingdom
Postcode: OX1 2EP
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.
Laparoscopic motorized instrument control unit
Type: General Medical Device
Manufacturer: American Orthodontics Corp
Chloride (Cl-) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Total creatine kinase (CK) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Multiple clinical chemistry analyser IVD, laboratory
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Potassium (K+) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Sodium (Na+) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
High density lipoprotein (HDL) cholesterol IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Total protein IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Urea IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH
Albumin IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

