United Kingdom MHRA device registration 127439

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Fast Track Diagnostics Luxembourg SARL·Registered Nov 26, 2024

Registration details

Device ID: 127439
MHRA Reference Number: 127439
Date Registered: Nov 26, 2024
Last Updated: Oct 9, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Fast Track Diagnostics Luxembourg SARL
Address: 29, rue Henri Koch, Esch-sur-Alzette
Luxembourg, Luxembourg
Created Date: Nov 17, 2021

Authorized Representative

Name: Siemens Healthcare Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Park View Watchmoor Park
Surrey, Camberley, England, United Kingdom
Postcode: GU15 3YL

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About this record

SARS-CoV-2 nucleic acid 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 127439. The device is manufactured by Fast Track Diagnostics Luxembourg SARL from Luxembourg, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Siemens Healthcare Diagnostics Limited.

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