Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Leukaemia-associated fusion gene 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 148426. 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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Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 148426•Ref: 148426

Device Type

In Vitro Diagnostic Device

Devices

Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Feb 9, 2024

Manufacturer Information

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

DJ Fang

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Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

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