United Kingdom MHRA device registration 117605

Multiple bloodstream bacteria nucleic acid IVD, control

United Kingdom·In Vitro Diagnostic Device·T2 Biosystems Inc·Registered Nov 26, 2024

Registration details

Device ID: 117605
MHRA Reference Number: 117605
Date Registered: Nov 26, 2024
Last Updated: Aug 21, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple bloodstream bacteria nucleic acid IVD, control
Type: IVD General

Manufacturer

Name: T2 Biosystems Inc
Address: 101 Hartwell Avenue Lexington
Massachusetts, Massachusetts, United States
Created Date: Dec 6, 2021

Authorized Representative

Name: Werfen Ltd
Relationship Type: UK Responsible Person
Address: 712 The Quadrant, Cavendish Avenue, Birchwood, Warrington WA3 6DE Manchester
Manchester, England, United Kingdom
Postcode: WA3 6DE

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About this record

Multiple bloodstream bacteria nucleic acid IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 117605. The device is manufactured by T2 Biosystems Inc from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Werfen Ltd.

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