United Kingdom MHRA device registration 87946

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

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

Registration details

Device ID: 87946
MHRA Reference Number: 87946
Date Registered: Oct 9, 2024
Last Updated: Aug 29, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Type: IVD Annex II List B

Manufacturer

Name: Beckman Coulter Inc.
Address: 250 South Kraemer Boulevard
Brea, California, United States
Created Date: Apr 29, 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

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About this record

Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 87946. 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.

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