United Kingdom MHRA device registration 100942

HLA class II antigen tissue typing IVD, kit, multiplex

United Kingdom·In Vitro Diagnostic Device·CareDx AB·Registered Nov 26, 2024

Registration details

Device ID: 100942
MHRA Reference Number: 100942
Date Registered: Nov 26, 2024
Last Updated: Jul 4, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: HLA class II antigen tissue typing IVD, kit, multiplex
Type: IVD Annex II List B

Manufacturer

Name: CareDx AB
Address: Franzéngatan 5
Stockholm, Sweden
Created Date: Aug 30, 2021

Authorized Representative

Name: QAdvis UK Ltd
Relationship Type: UK Responsible Person
Address: 55-66 Frederick Street
Edinburgh, EH2 1LS, Scotland, United Kingdom
Postcode: EH2 1LS

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About this record

HLA class II antigen tissue typing IVD, kit, multiplex is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 100942. The device is manufactured by CareDx AB from Sweden, classified as In Vitro Diagnostic Device. The authorized representative in the UK is QAdvis UK Ltd.

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