United Kingdom MHRA device registration 121331

Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)

United Kingdom·In Vitro Diagnostic Device·3B BlackBio Dx Limited·Registered Nov 26, 2024

Registration details

Device ID: 121331
MHRA Reference Number: 121331
Date Registered: Nov 26, 2024
Last Updated: Oct 9, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)
Type: IVD General

Manufacturer

Name: 3B BlackBio Dx Limited
Address: 7-C, Industrial Area, Govindpura
Bhopal, Madhya Pradesh, India
Created Date: Nov 23, 2021

Authorized Representative

Name: Wellkang Ltd
Relationship Type: Authorised Representative (Northern Ireland)
Address: Enterprise Hub, NW Business Complex 1 Beraghmore Road
Derry, Northern Ireland, Northern Ireland, United Kingdom
Postcode: BT48 8SE

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About this record

Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 121331. The device is manufactured by 3B BlackBio Dx Limited from India, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Wellkang Ltd.

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