United Kingdom MHRA device registration 175574

D-dimer IVD, kit, fluorescent immunoassay

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·BIOSYNEX SA·Registered Nov 26, 2024
Registration details
Device ID
175574
MHRA Reference Number
175574
Date Registered
Nov 26, 2024
Last Updated
May 9, 2024
Device classification
Device Type
In Vitro Diagnostic Device
Devices
D-dimer IVD, kit, fluorescent immunoassay
Type
IVD General
Manufacturer
Address
22 Boulevard Sebastien Brant ILLKIRCH-GRAFFENSTADEN
Strasbourg, Bas-Rhin, France
Created Date
Jun 24, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY
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About this record

D-dimer IVD, kit, fluorescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 175574. The device is manufactured by BIOSYNEX SA from France, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

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