United Kingdom MHRA device registration 147336

Leukaemia-associated fusion gene IVD, control

United Kingdom·In Vitro Diagnostic Device·3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)·Registered Nov 26, 2024

Registration details

Device ID: 147336
MHRA Reference Number: 147336
Date Registered: Nov 26, 2024
Last Updated: Feb 9, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Leukaemia-associated fusion gene IVD, control
Type: IVD General

Manufacturer

Name: 3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)
Address: 7-C, Industrial Area Govindpura Bhopal
Bhopal, India
Created Date: May 13, 2022

Authorized Representative

Name: Wellkang Ltd
Relationship Type: UK Responsible Person
Address: 16 Castle St.
Dover, Kent, England, United Kingdom
Postcode: CT16 1PW

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About this record

Leukaemia-associated fusion gene IVD, control is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 147336. The device is manufactured by 3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited) from India, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

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