Blood test-based differential diagnosis interpretive software IVD - UK MHRA Medical Device Registration

Blood test-based differential diagnosis interpretive software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 71845. The device is manufactured by Fibronostics US Inc. from United States, 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

🇬🇧

Blood test-based differential diagnosis interpretive software IVD

MHRA Device ID: 71845•Ref: 71845

Device Type

In Vitro Diagnostic Device

Devices

Blood test-based differential diagnosis interpretive software IVD

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jul 31, 2024

Manufacturer Information

Name

Fibronostics US Inc.

Address

274 E. Eau Gallie Blvd. #346, Indian Harbour Beach

Orlando, Florida, United States

Created Date

Apr 6, 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 Same Authorized Representative (10)

Blood test-based differential diagnosis interpretive software IVD - 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

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

Multiple clinical chemistry analyser IVD, laboratory

Smooth muscle antibody IVD, control

HVA/VMA/5HIAA IVD, kit, liquid chromatography

Levetiracetam therapeutic drug monitoring IVD, calibrator

Levetiracetam therapeutic drug monitoring IVD, control

Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD

Metanephrine IVD, kit, liquid chromatography

Multiple biogenic amine neurotransmitter IVD, control

Mitochondrial antibody M2 (anti-Mi2) IVD, control