SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical - UK MHRA Medical Device Registration

SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 77827. The device is manufactured by Prometheus Bio Inc from China, 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

🇬🇧

SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

MHRA Device ID: 77827•Ref: 77827

Device Type

In Vitro Diagnostic Device

Devices

SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

May 17, 2024

Manufacturer Information

Name

Prometheus Bio Inc

Address

2nd floor, No. 3, 8th Street, Qiantang Area,

Hangzhou, Zhejiang, China

Created Date

Apr 29, 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 Prometheus Bio Inc (9)

Other Products from Same Authorized Representative (10)

SARS-CoV-1/SARS-CoV-2 antigen 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

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

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay

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

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

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Vaginal speculum, single-use

Vascular port administration set

General-purpose patient temperature probe, reusable

Electrocardiographic lead set, reusable

General-purpose patient temperature probe, single-use

Pulse oximetry telemetric monitoring system

Tracheostomy tube speech valve

Electrode conductive skin pad, reusable

External defibrillation electrode, adult, single-use

Basic intravenous administration set, invasive