Coagulation factor VIII IVD, kit, chromogenic - UK MHRA Medical Device Registration

Coagulation factor VIII IVD, kit, chromogenic is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 92329. The device is manufactured by Immucor GTI Diagnostics, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MT Promedt Consulting 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

🇬🇧

Coagulation factor VIII IVD, kit, chromogenic

MHRA Device ID: 92329•Ref: 92329

Device Type

In Vitro Diagnostic Device

Devices

Coagulation factor VIII IVD, kit, chromogenic

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jun 7, 2024

Manufacturer Information

Name

Immucor GTI Diagnostics, Inc.

Address

20925 Crossroad Circle

Waukesha, Wisconsin, United States

Created Date

Aug 4, 2021

Authorized Representative

Name

MT Promedt Consulting Ltd

Relationship Type

UK Responsible Person

Address

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Immucor GTI Diagnostics, Inc. (10)

Other Products from Same Authorized Representative (10)

Coagulation factor VIII IVD, kit, chromogenic - 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

HLA class II antigen tissue typing IVD, kit, multiplex

HLA class I antigen tissue typing IVD, kit, multiplex

Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, multiplex

Laboratory instrument/analyser application software IVD

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

HLA class I antigen tissue typing IVD, kit, multiplex

Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

HLA class I & II antigen tissue typing IVD, kit, multiplex

Laparoscopic motorized instrument control unit

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Electrocardiographic lead set, reusable

Anaesthesia breathing circuit, single-use

Carbon dioxide absorbent cartridge

Carbon dioxide absorber, single-use

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Electrocardiographic lead set, single-use

Electrocardiographic lead switching adaptor

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical