SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 77828. 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.

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

MHRA Device ID: 77828•Ref: 77828

Device Type

In Vitro Diagnostic Device

Devices

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

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

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SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay - UK MHRA Medical Device Registration

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