Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 205641. The device is manufactured by Diesse Diagnostica Senese Spa from Italy, classified as In Vitro Diagnostic Device. The authorized representative in the UK is IVDeology UKRP 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.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 205641•Ref: 205641

Device Type

In Vitro Diagnostic Device

Devices

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Type

Class C

Date Registered

Nov 26, 2024

Last Updated

Oct 25, 2024

Manufacturer Information

Name

Diesse Diagnostica Senese Spa

Address

Diesse Diagnostica Senese Spa Viale Decumano 36

Milan, Italy

Created Date

Jul 8, 2021

Authorized Representative

Name

IVDeology UKRP Ltd

Relationship Type

UK Responsible Person

Address

Maidstone Innovation Centre Gidds Pond Way

Maidstone, Kent, England, United Kingdom

Postcode: ME14 5FY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Diesse Diagnostica Senese Spa (10)

Other Products from Same Authorized Representative (10)

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Buffered sample diluent IVD, manual

Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Enzyme immunoassay (EIA) analyser IVD

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Evacuated erythrocyte sedimentation rate (ESR) tube IVD

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, enzyme immunoassay (EIA)

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Oral/respiratory tract specimen container IVD, additive/medium