United Kingdom MHRA device registration 135693

Quetiapine therapeutic drug monitoring IVD, reagent

United Kingdom·In Vitro Diagnostic Device·Saladax Biomedical, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 135693
MHRA Reference Number: 135693
Date Registered: Nov 26, 2024
Last Updated: Apr 17, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Quetiapine therapeutic drug monitoring IVD, reagent
Type: IVD General

Manufacturer

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

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About this record

Quetiapine therapeutic drug monitoring IVD, reagent is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 135693. 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 .

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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