United Kingdom MHRA device registration 150595

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ·Registered Nov 26, 2024

Registration details

Device ID: 150595
MHRA Reference Number: 150595
Date Registered: Nov 26, 2024
Last Updated: Apr 5, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ
Address: Hasanpasa Mah. Beydagi Sk No: 1-9 H
Istanbul, Sultanbeyli, Turkey
Created Date: Apr 28, 2021

Authorized Representative

Name: Launch Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Unit 20 Ash Way Thorp Arch Estate
Wetherby, England, United Kingdom
Postcode: LS23 7FA

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About this record

BK virus (BKV) nucleic acid 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 150595. The device is manufactured by Anatolia Tanı ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AŞ from Turkey, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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