United Kingdom MHRA device registration 172532

D-dimer IVD, calibrator

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Beckman Coulter Inc.·Registered Nov 26, 2024
Registration details
Device ID
172532
MHRA Reference Number
172532
Date Registered
Nov 26, 2024
Last Updated
Aug 29, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
D-dimer IVD, calibrator
Type
Class C
Manufacturer
Address
250 South Kraemer Boulevard
Brea, California, United States
Created Date
Apr 29, 2021
Authorized Representative
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 Inc.

Additional devices registered by the same manufacturer

Other products from same authorized representative

Additional devices represented by Beckman Coulter UK Ltd in the UK

Albumin IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 120792
Albumin IVD, kit, spectrophotometryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 103517
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 205712
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 103495
Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 205716
Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)Nov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 120802
Antithrombin III (ATIII) IVD, reagentNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 205720
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 103493
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibratorNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 112508
Acetylcholinesterase IVD, kit, spectrophotometryNov 26, 2024
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Inc.
Device ID: 172543
About this record

D-dimer IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 172532. The device is manufactured by Beckman Coulter Inc. from United States, 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