Multiple Coeliac disease-associated antibody IVD, control - UK MHRA Medical Device Registration

Multiple Coeliac disease-associated antibody IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 125516. The device is manufactured by INOVA Diagnostics from United States, 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

🇬🇧

Multiple Coeliac disease-associated antibody IVD, control

MHRA Device ID: 125516•Ref: 125516

Device Type

In Vitro Diagnostic Device

Devices

Multiple Coeliac disease-associated antibody IVD, control

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 22, 2024

Manufacturer Information

Name

INOVA Diagnostics

Address

9900 Old Grove Road

San Diego, United States

Created Date

Dec 21, 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 INOVA Diagnostics (10)

Other Products from Same Authorized Representative (10)

Multiple Coeliac disease-associated antibody IVD, control - 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

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Buffered sample diluent IVD, manual

Calprotectin IVD, control

Cell morphology analyser IVD, manual

Cell morphology analyser IVD, manual

Complement component C1q IVD, kit, enzyme immunoassay (EIA)

Double stranded DNA antibody (anti-dsDNA) IVD, calibrator

Endomysium antibody (EMA) IVD, control

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay

Coagulation analyser IVD, point-of-care, line-powered

Platelet aggregation analyser IVD

Coagulation analyser IVD, point-of-care, line-powered

Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent

Buffered sample diluent IVD

Buffered sample diluent IVD, automated/semi-automated system

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Culture tube

Blood lancet, single-use