Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 153043. The device is manufactured by Exosome Diagnostics Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 153043•Ref: 153043

Device Type

In Vitro Diagnostic Device

Devices

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Jul 28, 2022

Last Updated

Dec 22, 2022

Manufacturer Information

Name

Exosome Diagnostics Inc.

Address

266 Second Ave. Suite 200

Waltham, Massachusetts, United States

Created Date

Jul 28, 2022

Authorized Representative

Name

Emergo Consulting (UK) Limited

Relationship Type

UK Responsible Person

Address

Compass House, Vision Park Histon c/o Cr360 – UL International

Cambridge, England, United Kingdom

Postcode: CB24 9BZ

DJ Fang

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Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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