5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, reagent - UK MHRA Medical Device Registration

5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 128551. The device is manufactured by Saladax Biomedical, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Emergo Consulting (UK) Limited .

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5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, reagent

MHRA Device ID: 128551•Ref: 128551

Device Type

In Vitro Diagnostic Device

Devices

5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, reagent

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Apr 17, 2024

Manufacturer Information

Name

Saladax Biomedical, Inc.

Address

116 Research Drive

Bethlehem, Pennsylvania, United States

Created Date

Dec 27, 2021

Authorized Representative

Name

Emergo Consulting (UK) Limited

Relationship Type

UK Responsible Person

Address

Compass House, Vision Park Histon c/o Cr360 – UL International

Cambridge, England, United Kingdom

Postcode: CB24 9BZ

DJ Fang

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5-Fluorouracil (5-FU) therapeutic drug monitoring IVD, reagent - UK MHRA Medical Device Registration

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