United Kingdom MHRA device registration 116451

p53 tumour protein antibody IVD, calibrator

United Kingdom·In Vitro Diagnostic Device·Roche Diagnostics GmbH·Registered Nov 26, 2024

Registration details

Device ID: 116451
MHRA Reference Number: 116451
Date Registered: Nov 26, 2024
Last Updated: Oct 10, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: p53 tumour protein antibody IVD, calibrator
Type: Class C

Manufacturer

Name: Roche Diagnostics GmbH
Address: Sandhofer Strasse 116
Mannheim, Germany
Created Date: Apr 19, 2021

Authorized Representative

Name: Roche Diagnostics Limited
Relationship Type: UK Responsible Person
Address: Roche Diagnostics Limited Charles Avenue
Burgess Hill, West Sussex, United Kingdom
Postcode: RH15 9RY

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About this record

p53 tumour protein antibody IVD, calibrator is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 116451. The device is manufactured by Roche Diagnostics GmbH from Germany, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Roche Diagnostics Limited.

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