United Kingdom MHRA device registration 69004

Free (unbound) prostate specific antigen (fPSA) IVD, control

United Kingdom·In Vitro Diagnostic Device·Abbott Ireland Diagnostics Division·Registered Nov 26, 2024

Registration details

Device ID: 69004
MHRA Reference Number: 69004
Date Registered: Nov 26, 2024
Last Updated: May 22, 2024

Device classification

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

Manufacturer

Name: Abbott Ireland Diagnostics Division
Address: Finisklin Business Park
Sligo, Ireland
Created Date: Mar 9, 2021

Authorized Representative

Name: Abbott Laboratories Limited
Relationship Type: UK Responsible Person
Address: Abbott House, Vanwall Business Park, Vanwall Road
Maidenhead, Berkshire, England, United Kingdom
Postcode: SL64XE

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About this record

Free (unbound) prostate specific antigen (fPSA) IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 69004. The device is manufactured by Abbott Ireland Diagnostics Division from Ireland, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Abbott Laboratories Limited.

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