United Kingdom MHRA device registration 194357

Multiple thyroid marker IVD, control

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Bifour Biotech Inc.·Registered Nov 26, 2024
Registration details
Device ID
194357
MHRA Reference Number
194357
Date Registered
Nov 26, 2024
Last Updated
May 31, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Multiple thyroid marker IVD, control
Type
IVD General
Manufacturer
Address
4677 Old Ironsides Drive, Suite 300,Santa Clara
California, United States
Created Date
May 24, 2024
Authorized Representative
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

Multiple thyroid marker IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 194357. 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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