Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration
Mycoplasma pneumoniae immunoglobulin M (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 207999. The device is manufactured by Zhejiang Orient Gene 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 General
Status
Date Registered
Jan 7, 2025
Address
3787#, East Yangguang Avenue, Dipu Street, Anji, Huzhou
Zhejiang, 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.
Human metapneumovirus (hMPV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Mar 20, 2025
Multiple gastrointestinal disease marker IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Feb 20, 2025
Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Feb 20, 2025
Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025
SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025
Procalcitonin (PCT) IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025
Chikungunya virus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025
Multiple Candida species antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025
Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025
Rheumatoid factor IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Registered: Jan 7, 2025

