United Kingdom MHRA device registration 164831

CD64 cell marker IVD, antibody

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Sysmex Partec GmbH·Registered Nov 26, 2024
Registration details
Device ID
164831
MHRA Reference Number
164831
Date Registered
Nov 26, 2024
Last Updated
Oct 17, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
CD64 cell marker IVD, antibody
Type
IVD General
Manufacturer
Address
Arndtstraße 11 a-b
Görlitz, Germany
Created Date
Jan 16, 2023
Authorized Representative
Relationship Type
UK Responsible Person
Address
Sysmex House Garamonde Drive Wymbush
Milton Keynes, Buckinghamshire, England, United Kingdom
Postcode: MK8 8DF
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About this record

CD64 cell marker IVD, antibody is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 164831. The device is manufactured by Sysmex Partec GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Sysmex UK Ltd.

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