Legionella pneumophila immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Legionella pneumophila immunoglobulin M (IgM) 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 189482. The device is manufactured by Gold Standard Diagnostics Frankfurt GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen 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

🇬🇧

Legionella pneumophila immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 189482•Ref: 189482

Device Type

In Vitro Diagnostic Device

Devices

Legionella pneumophila immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Aug 21, 2024

Manufacturer Information

Name

Gold Standard Diagnostics Frankfurt GmbH

Address

Waldstrasse 23 A6

Dietzenbach, Germany

Created Date

Dec 30, 2021

Authorized Representative

Name

Werfen Ltd

Relationship Type

UK Responsible Person

Address

712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester

Manchester, England, United Kingdom

Postcode: WA3 6DE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Gold Standard Diagnostics Frankfurt GmbH (10)

Other Products from Same Authorized Representative (10)

Legionella pneumophila immunoglobulin M (IgM) 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

Yersinia enterocolitica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Yersinia enterocolitica immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA)

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

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

Clostridium tetani immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Coagulation analyser IVD, laboratory, semi-automated

Multiple blood gas analyte IVD, reagent

Multiple coagulation factor IVD, control

Multiple coagulation factor IVD, reagent

Platelet aggregation study IVD, reagent

Prothrombin time (PT) IVD, reagent

ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination

Anti-K (KEL001) red blood cell grouping IVD, antibody

Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Activated partial thromboplastin time (APTT) IVD, reagent