United Kingdom MHRA device registration 194340

Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

United Kingdom·In Vitro Diagnostic Device·Bifour Biotech Inc.·Registered Nov 26, 2024

Registration details

Device ID: 194340
MHRA Reference Number: 194340
Date Registered: Nov 26, 2024
Last Updated: May 31, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
Type: IVD General

Manufacturer

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

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About this record

Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 194340. 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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