United Kingdom MHRA device registration 191100

Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

United Kingdom·In Vitro Diagnostic Device·TestLine Clinical Diagnostics s.r.o·Registered Nov 26, 2024

Registration details

Device ID: 191100
MHRA Reference Number: 191100
Date Registered: Nov 26, 2024
Last Updated: Nov 12, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
Type: IVD General

Manufacturer

Name: TestLine Clinical Diagnostics s.r.o
Address: Křižíkova 188/68
Brno, Czechia
Created Date: Nov 24, 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

Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 191100. The device is manufactured by TestLine Clinical Diagnostics s.r.o from Czechia, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Oxford Biosystems Ltd.

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