SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing - UK MHRA Medical Device Registration
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 171641. The device is manufactured by Beijing Hotgen Biotech Co Ltd from China, classified as In Vitro Diagnostic Device.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, 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
Type
IVD Devices for Self-Testing
Status
Date Registered
Jun 22, 2024
Address
6th, 7th and 9th Buildings, No, 55 Qingfeng West Road
Daxing District, Beijing, China
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.
Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2021
SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2021
SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2021
Monkeypox virus antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2021

