Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

Gentamicin 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 151636. 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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Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 151636•Ref: 151636

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 3, 2024

Manufacturer Information

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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Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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