Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT) - UK MHRA Medical Device Registration

Monkeypox virus 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 153540. The device is manufactured by VivaChek Biotech (Hangzhou) Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is lotus global co 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

🇬🇧

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

MHRA Device ID: 153540•Ref: 153540

Device Type

In Vitro Diagnostic Device

Devices

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jun 11, 2024

Manufacturer Information

Name

VivaChek Biotech (Hangzhou) Co., Ltd.

Address

Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone,

Hangzhou, Zhejiang, China

Created Date

Mar 14, 2021

Authorized Representative

Name

lotus global co ltd

Relationship Type

UK Responsible Person

Address

23 Maine Street

Reading, Reading, England, United Kingdom

Postcode: RG2 6AG

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from VivaChek Biotech (Hangzhou) Co., Ltd. (10)

Other Products from Same Authorized Representative (10)

Monkeypox virus nucleic acid 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

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Prothrombin time (PT) IVD, reagent

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Legionella pneumophila 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

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay

Glucose IVD, control

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

Anti-Mullerian hormone (AMH) IVD, reagent

Cystatin C IVD, reagent

Faecal occult blood IVD, reagent

Fluorescent immunoassay analyser IVD, point-of-care, line-powered

Follicle stimulating hormone (FSH) IVD, reagent

Free triiodothyronine (FT3) IVD, reagent

Haemoglobin detection IVD, control

Glucose IVD, reagent

Haemoglobin detection IVD, control

Multiple lipid analyte IVD, kit, rapid colorimetric, clinical

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, clinical

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, reagent

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, reagent

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Morphine/morphine metabolite IVD, kit, rapid ICT, clinical