United Kingdom MHRA device registration 112951

Amyloid B component IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Fujirebio Europe N.V.·Registered Nov 26, 2024

Registration details

Device ID: 112951
MHRA Reference Number: 112951
Date Registered: Nov 26, 2024
Last Updated: May 9, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Amyloid B component IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Fujirebio Europe N.V.
Address: Technologiepark 6
Gent, Oost-Vlaanderen, Belgium
Created Date: Apr 13, 2021

Authorized Representative

Name: Qarad UK Ltd.
Relationship Type: UK Responsible Person
Address: 8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY

Similar products

Devices with a matching generic name or device type registered with MHRA

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176179

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176185

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175386

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

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176184

C-reactive protein (CRP) IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176164

Cryptosporidium species antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176139

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175389

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175394

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinicalN/A

Type: In Vitro Diagnostic Device

Manufacturer: Primer Design Ltd

Device ID: 175395

D-dimer IVD, kit, fluorescent immunoassayN/A

Type: In Vitro Diagnostic Device

Manufacturer: Vitrosens Biyoteknoloji A.S.

Device ID: 176162

Other products from Fujirebio Europe N.V.

Additional devices registered by the same manufacturer

Tau protein IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 183173

Digital imaging scanner/reader calibration card IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 155590

Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 185931

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 112954

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 185930

Human placental alkaline phosphatase (hPLAP) IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 112947

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 185933

Laboratory instrument/analyser application software IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 112952

Laboratory instrument/analyser application software IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 125930

Line probe assay interpretation template IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 155587

Other products from same authorized representative

Additional devices represented by Qarad UK Ltd. in the UK

Citrate IVD, kit, spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195362

Ethyl glucuronide (EtG) IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195366

Ethyl glucuronide (EtG) IVD, kit, mass spectrometryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195364

Free cortisol/cortisone IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195374

Free cortisol/cortisone IVD, kit, liquid chromatography/mass spectrometry (LC/MS)Nov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195373

HVA/VMA/5HIAA IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195337

Levetiracetam therapeutic drug monitoring IVD, kit, liquid chromatographyNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195353

Multiple biogenic amine neurotransmitter IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195334

Multiple form 25-hydroxy Vitamin D IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 195372

Multiple immunosuppressant therapeutic drug monitoring IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: EUREKA S.R.L. LAB DIVISION

Device ID: 205072

About this record

Amyloid B component IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 112951. The device is manufactured by Fujirebio Europe N.V. from Belgium, 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 DatabasePowered by Pure Global AIMHRA RegisteredIn Vitro Diagnostic Device