United Kingdom MHRA device registration 192304

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·BIOTYPE GmbH·Registered Nov 26, 2024

Registration details

Device ID: 192304
MHRA Reference Number: 192304
Date Registered: Nov 26, 2024
Last Updated: May 9, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: BIOTYPE GmbH
Address: Moritzburger Weg 67
Dresden, Germany
Created Date: Apr 26, 2024

Authorized Representative

Name: Qarad UK Ltd.
Relationship Type: UK Responsible Person
Address: 8 Northumberland Ave
Westminster, London , England, United Kingdom
Postcode: WC2N 5BY

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About this record

Acute myeloid leukaemia (AML) genetic mutation 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 192304. The device is manufactured by BIOTYPE GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

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