United Kingdom MHRA device registration 86182

Thermal cycler nucleic acid amplification analyser IVD, laboratory

United Kingdom·In Vitro Diagnostic Device·BioFire Diagnostics, LLC·Registered Nov 26, 2024

Registration details

Device ID: 86182
MHRA Reference Number: 86182
Date Registered: Nov 26, 2024
Last Updated: Apr 5, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Thermal cycler nucleic acid amplification analyser IVD, laboratory
Type: IVD General

Manufacturer

Name: BioFire Diagnostics, LLC
Address: 515 Colorow Drive Salt Lake City
Utah, Salt Lake City, United States
Created Date: Apr 8, 2021

Authorized Representative

Name: bioMérieux UK Ltd
Relationship Type: UK Responsible Person
Address: Chineham Gate Crockford Lane
Basingstoke, Hampshire, England, United Kingdom
Postcode: RG24 8NA

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About this record

Thermal cycler nucleic acid amplification analyser IVD, laboratory is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 86182. The device is manufactured by BioFire Diagnostics, LLC from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is bioMérieux UK Ltd.

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