United Kingdom MHRA device registration 80985

BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique

United Kingdom·In Vitro Diagnostic Device·Entrogen Inc.·Registered Jun 17, 2024

Registration details

Device ID: 80985
MHRA Reference Number: 80985
Date Registered: Jun 17, 2024
Last Updated: Apr 23, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique
Type: IVD General

Manufacturer

Name: Entrogen Inc.
Address: Suite B 20950 Warner Center Ln Woodland Hills
Los Angeles, CA, United States
Created Date: May 17, 2021

Authorized Representative

Name: Launch Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Unit 20 Ash Way Thorp Arch Estate
Wetherby, England, United Kingdom
Postcode: LS23 7FA

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About this record

BRCA1/BRCA2 genotyping IVD, kit, nucleic acid sequencing technique is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 80985. The device is manufactured by Entrogen Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Launch Diagnostics Limited.

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