Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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

MHRA Device ID: 87946•Ref: 87946

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD Annex II List B

Date Registered

Oct 9, 2024

Last Updated

Aug 29, 2024

Manufacturer Information

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

DJ Fang

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Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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