Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 171002. The device is manufactured by Biomerica, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MDSS-UK RP LIMITED.

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In Vitro Diagnostic Device

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Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical

MHRA Device ID: 171002•Ref: 171002

Device Type

In Vitro Diagnostic Device

Devices

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical

Type

IVD Annex II List B

Date Registered

Nov 26, 2024

Last Updated

Jan 25, 2024

Manufacturer Information

Name

Biomerica, Inc.

Address

17571 VON KARMAN AVE.

Irvine, CA, United States

Created Date

Apr 17, 2023

Authorized Representative

Name

MDSS-UK RP LIMITED

Relationship Type

UK Responsible Person

Address

6 Wilmslow Road, Rusholme

Manchester, England, United Kingdom

Postcode: M14 5TP

DJ Fang

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Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

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