SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 76148. 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

🇬🇧

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

MHRA Device ID: 76148•Ref: 76148

Device Type

In Vitro Diagnostic Device

Devices

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

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)

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Clostridium difficile antigen IVD, antibody

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay

Troponin I IVD, kit, fluorescent immunoassay

Prolactin IVD, kit, fluorescent immunoassay

Rotavirus antigen IVD, kit, rapid ICT, clinical

Troponin T IVD, kit, fluorescent immunoassay

Total cortisol IVD, reagent

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

Bronchial balloon catheter

Indexed-immobilization patient positioning system

Patient surgical drape, single-use

Metered-delivery hypodermic syringe/needle

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Alternating-pressure bed mattress

Vinyl examination/treatment glove, non-powdered

ENFit oral/enteral syringe, reusable

ENFit oral/enteral syringe, single-use

Catheter/overtube balloon inflator, single-use