United Kingdom MHRA device registration 159489

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid sequencing technique

United Kingdom·In Vitro Diagnostic Device·Biovendor - Laboratorni medicina a.s.·Registered Sep 24, 2024

Registration details

Device ID: 159489
MHRA Reference Number: 159489
Date Registered: Sep 24, 2024
Last Updated: Sep 11, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid sequencing technique
Type: IVD General

Manufacturer

Name: Biovendor - Laboratorni medicina a.s.
Address: Karasek 1767/1
Brno, Czechia
Created Date: Jul 8, 2022

Authorized Representative

Name: Oxford Biosystems Ltd
Relationship Type: UK Responsible Person
Address: 184B Park Drive Milton Park Abingdon
Abingdon, Oxfordshire, United Kingdom
Postcode: OX14 4SE

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About this record

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid sequencing technique is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 159489. The device is manufactured by Biovendor - Laboratorni medicina a.s. from Czechia, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Oxford Biosystems Ltd.

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