United Kingdom MHRA device registration 153027

Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

United Kingdom·In Vitro Diagnostic Device·Beckman Coulter Ireland Inc.·Registered Oct 9, 2024

Registration details

Device ID: 153027
MHRA Reference Number: 153027
Date Registered: Oct 9, 2024
Last Updated: Aug 29, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Type: IVD General

Manufacturer

Name: Beckman Coulter Ireland Inc.
Address: Lismeehan
O'Callaghan's Mills, Co. Clare, Ireland
Created Date: Nov 11, 2021

Authorized Representative

Name: Beckman Coulter UK Ltd
Relationship Type: UK Responsible Person
Address: Oakley Court Kingsmead Busines sPark London Rd
High Wycombe, Bucks, United Kingdom
Postcode: HP11 1JU

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 Beckman Coulter Ireland Inc.

Additional devices registered by the same manufacturer

Creatine kinase (CK) multiple isoenzyme IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 167140

Multiple CD cell marker IVD, controlNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 167154

Carbon dioxide (CO2) IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 180465

Carbon dioxide (CO2) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 187174

Creatinine IVD, kit, enzyme spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 167144

Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 167142

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 187168

Amylase isoenzyme IVD, kit, spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 167156

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 112586

Multiple drugs of abuse IVD, calibratorNov 26, 2024

Type: In Vitro Diagnostic Device

Device ID: 112585

Other products from same authorized representative

Additional devices represented by Beckman Coulter UK Ltd in the UK

25-Hydroxy vitamin D2 IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172599

Alanine aminotransferase (ALT) IVD, kit, spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 205693

Albumin IVD, kit, spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172708

Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172538

Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 103496

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 205711

Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 103508

Antithrombin III (ATIII) IVD, reagentNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 103511

Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetryNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Beckman Coulter Inc.

Device ID: 172555

Laboratory instrument/analyser control unit IVDNov 26, 2024

Type: In Vitro Diagnostic Device

Manufacturer: Sener Diagnostics, S.A.

Device ID: 205060

About this record

Digitoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 153027. The device is manufactured by Beckman Coulter Ireland Inc. from Ireland, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Beckman Coulter 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