SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 80966. The device is manufactured by Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology 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

🇬🇧

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

MHRA Device ID: 80966•Ref: 80966

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Feb 20, 2024

Manufacturer Information

Name

Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd.

Address

Bldg. 2 and R101-R105/R201-240 of Bldg. 5, 568 Binkang Rd., Binjiang Dist.,

Hangzhou, , Zhejiang, China

Created Date

Feb 26, 2021

Authorized Representative

Name

NPZ technology Ltd

Relationship Type

UK Responsible Person

Address

Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach

Cambridge, Cambridgeshire, United Kingdom

Postcode: CB25 9QE

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Hangzhou Zheda Dixun Biological Gene Engineering Co.,Ltd. (9)

Other Products from Same Authorized Representative (10)

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) - 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

Blot processor IVD

Immunoassay reagent vehicle reader IVD

Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay

Multiple allergen-specific immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 total antibody IVD, kit, rapid ICT, clinical

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 neutralizing antibody IVD, kit, fluorescent immunoassay, rapid

Flexible endoscopic biopsy forceps, single-use

Oesophageal bougie, single-use

First aid absorbent pad/bandage

Skin-cover adhesive strip, non-antimicrobial

Synthetic polymer semi-permeable film dressing, adhesive

Dental digital imaging sensor, intraoral

Dental power tool system handpiece, battery-powered

Dental surgical power tool motorized handpiece/set, electric

Dental/surgical polymerization lamp

Endoscopic bite block, basic, single-use