Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 112039. The device is manufactured by ORGENTEC Diagnostika GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK 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

🇬🇧

Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 112039•Ref: 112039

Device Type

In Vitro Diagnostic Device

Devices

Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jun 15, 2024

Manufacturer Information

Name

ORGENTEC Diagnostika GmbH

Address

Carl-Zeiss-Str. 49-51

Mainz, Rheinhessen-Pfalz, Germany

Created Date

Aug 10, 2021

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from ORGENTEC Diagnostika GmbH (10)

Other Products from Same Authorized Representative (10)

Prothrombin antibody (anti-prothrombin) 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

Enzyme immunoassay (EIA) analyser IVD

Albumin IVD, kit, enzyme immunoassay (EIA)

Alpha-fodrin antibody IVD, enzyme immunoassay (EIA)

Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM 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)

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Centromere antibody IVD, kit, enzyme immunoassay (EIA)

Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Enzyme immunoassay (EIA) analyser IVD

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

Activated partial thromboplastin time (APTT) IVD, reagent

Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinical

Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)

Carcinoembryonic antigen (CEA) IVD, control

Coagulation analyser IVD, laboratory

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

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

Chemiluminescent immunoassay analyser IVD