Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator - UK MHRA Medical Device Registration
Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 172527. 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.
Device Type
In Vitro Diagnostic Device
Devices
Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Type
Class C
Date Registered
Nov 26, 2024
Last Updated
Aug 29, 2024
Address
250 South Kraemer Boulevard
Brea, California, United States
Created Date
Apr 29, 2021
Relationship Type
Address
Oakley Court Kingsmead Busines sPark London Rd
High Wycombe, Bucks, United Kingdom
Postcode: HP11 1JU
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Prothrombin time (PT) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Universal Biosensors Pty Ltd
Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Clostridium difficile antigen IVD, antibody
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Total cortisol IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Boditech Med Inc.
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Primer Design Ltd
Dengue virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Type: In Vitro Diagnostic Device
Manufacturer: Vitrosens Biyoteknoloji A.S.
Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2025
Hepatitis B virus surface total antibody IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2025
Hepatitis B virus surface total antibody IVD, control
Type: In Vitro Diagnostic Device
Registered: Feb 26, 2025
Creatinine IVD, kit, spectrophotometry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Complement factor B IVD, reagent
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Chromogen indicator IVD, kit, spectrophotometry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Cannabinoid/cannabinoid metabolite IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Ceruloplasmin IVD, kit, nephelometry/turbidimetry
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Lipoprotein A IVD, calibrator
Type: In Vitro Diagnostic Device
Registered: Nov 26, 2024
Amylase isoenzyme IVD, kit, spectrophotometry
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.
Creatine kinase (CK) multiple isoenzyme IVD, control
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.
Flow cytometry analyser IVD
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Biotechnology
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.
Carbon dioxide (CO2) IVD, calibrator
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.
Carbon dioxide (CO2) IVD, reagent
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.
Clinical laboratory information system application software
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Biomedical GmbH
Specimen processing instrument IVD
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Biomedical GmbH
2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.
Creatinine IVD, kit, enzyme spectrophotometry
Type: In Vitro Diagnostic Device
Manufacturer: Beckman Coulter Ireland Inc.

