United Kingdom MHRA device registration 125028

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Clark Laboratories, INC., dba Trinity Biotech USA·Registered Nov 26, 2024

Registration details

Device ID: 125028
MHRA Reference Number: 125028
Date Registered: Nov 26, 2024
Last Updated: Sep 27, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

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

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About this record

Epstein-Barr virus (EBV) 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 125028. 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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