United Kingdom MHRA device registration 151701

Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Microgenics Corporation·Registered Nov 26, 2024

Registration details

Device ID: 151701
MHRA Reference Number: 151701
Date Registered: Nov 26, 2024
Last Updated: Oct 3, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Microgenics Corporation
Address: 46500 Kato Road
Fremont, California, United States
Created Date: Jul 11, 2022

Authorized Representative

Name: Thermo Fisher Diagnostics Ltd.
Relationship Type: UK Responsible Person
Address: Stafford House Boundary Way
Hemel Hempstead, England, United Kingdom
Postcode: HP27GE

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About this record

Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 151701. The device is manufactured by Microgenics Corporation from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Thermo Fisher Diagnostics Ltd..

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