United Kingdom MHRA device registration 161681

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

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

Registration details

Device ID: 161681
MHRA Reference Number: 161681
Date Registered: Nov 26, 2024
Last Updated: Nov 12, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 161681. 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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