JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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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In Vitro Diagnostic Device

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

MHRA Device ID: 197570•Ref: 197570

Device Type

In Vitro Diagnostic Device

Devices

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

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

Jul 23, 2024

Manufacturer Information

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

DJ Fang

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JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) - UK MHRA Medical Device Registration

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