United Kingdom MHRA device registration 197570

JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·Innominata dba GenBio·Registered Nov 26, 2024

Registration details

Device ID: 197570
MHRA Reference Number: 197570
Date Registered: Nov 26, 2024
Last Updated: Jul 23, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: Innominata dba GenBio
Address: 15222 Avenue of Science Suite A
California, United States
Created Date: Jul 22, 2024

Authorized Representative

Name: MedEnvoy UK Limited
Relationship Type: UK Responsible Person
Address: 85 Great Portland Street First Floor
London, England, United Kingdom
Postcode: W1W 7LT

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About this record

JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 197570. The device is manufactured by Innominata dba GenBio from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is MedEnvoy UK Limited.

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