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 125031. The device is manufactured by Clark Laboratories, INC., dba Trinity Biotech USA from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is IVDeology UKRP Ltd.

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

MHRA Device ID: 125031•Ref: 125031

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

Sep 27, 2024

Manufacturer Information

Name

Clark Laboratories, INC., dba Trinity Biotech USA

Address

Clark Laboratories, INC., dba Trinity Biotech USA 2823 Girts Road

Jamestown, NY, United States

Created Date

Dec 21, 2021

Authorized Representative

Name

IVDeology UKRP Ltd

Relationship Type

UK Responsible Person

Address

Maidstone Innovation Centre Gidds Pond Way

Maidstone, Kent, England, United Kingdom

Postcode: ME14 5FY

DJ Fang

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

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