Cancer antigen 15-3 (CA15-3) IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

Cancer antigen 15-3 (CA15-3) IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 194338. The device is manufactured by Bifour Biotech Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is SUNGO Certification Company Limited.

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Cancer antigen 15-3 (CA15-3) IVD, kit, fluorescent immunoassay

MHRA Device ID: 194338•Ref: 194338

Device Type

In Vitro Diagnostic Device

Devices

Cancer antigen 15-3 (CA15-3) IVD, kit, fluorescent immunoassay

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

May 31, 2024

Manufacturer Information

Name

Bifour Biotech Inc.

Address

4677 Old Ironsides Drive, Suite 300,Santa Clara

California, United States

Created Date

May 24, 2024

Authorized Representative

Name

SUNGO Certification Company Limited

Relationship Type

UK Responsible Person

Address

3rd Floor, 70 Gracechurch Street

London, England, United Kingdom

Postcode: EC3V 0HR

DJ Fang

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Cancer antigen 15-3 (CA15-3) IVD, kit, fluorescent immunoassay - UK MHRA Medical Device Registration

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