Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Treponema pallidum total 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 161679. 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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Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 161679•Ref: 161679

Device Type

In Vitro Diagnostic Device

Devices

Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Nov 12, 2024

Manufacturer Information

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

DJ Fang

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Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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