Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Acute myeloid leukaemia (AML) genetic mutation 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 119964. 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.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 119964•Ref: 119964

Device Type

In Vitro Diagnostic Device

Devices

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Oct 9, 2024

Manufacturer Information

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

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from 3B BlackBio Dx Limited (10)

Other Products from Same Authorized Representative (10)

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Ankylosing spondylitis IVD, kit, nucleic acid technique (NAT)

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)

Calreticulin (CALR) gene mutation IVD, kit, nucleic acid technique (NAT)

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

JAK2 V617F gene mutation IVD, kit, nucleic acid technique (NAT)

Anaplastic lymphoma kinase (ALK) genetic mutation IVD, kit, nucleic acid technique (NAT)

Laparoscopic access cannula, single-use

Laparoscopic access cannula, single-use

Open-surgery manual linear stapler, single-use

Surgical clip remover, reusable

Tissue extraction bag

Fibreoptic operating light system

Head-worn fibreoptic light

External defibrillation electrode, paediatric, single-use

Surgical staple loading unit, non-cutting

Endoscopic manual linear cutting stapler, single-use