United Kingdom MHRA device registration 165194

Multiple respiratory virus nucleic acid IVD, calibrator

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Mobidiag Oy·Registered Apr 11, 2024
Registration details
Device ID
165194
MHRA Reference Number
165194
Date Registered
Apr 11, 2024
Last Updated
Mar 12, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
Multiple respiratory virus nucleic acid IVD, calibrator
Type
IVD General
Manufacturer
Address
Keilaranta 16A
Espoo, Finland
Created Date
Jan 20, 2023
Authorized Representative
Relationship Type
UK Responsible Person
Address
Heron House 6 The Oaks Business Park Crewe Road Wythenshawe
Manchester, Lancashire, England, United Kingdom
Postcode: M23 9HZ
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About this record

Multiple respiratory virus nucleic acid IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 165194. The device is manufactured by Mobidiag Oy from Finland, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Hologic Ltd..

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