United Kingdom MHRA device registration 85747

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

United Kingdom·In Vitro Diagnostic Device·InnaK Diagnostics, Inc.·Registered Nov 26, 2024

Registration details

Device ID: 85747
MHRA Reference Number: 85747
Date Registered: Nov 26, 2024
Last Updated: Apr 3, 2024

Device classification

Device Type: In Vitro Diagnostic Device
Devices: SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)
Type: IVD General

Manufacturer

Name: InnaK Diagnostics, Inc.
Address: 6720 Cobra Way, Suite L201,
San Diego, California, United States
Created Date: Jun 17, 2021

Authorized Representative

Name: NPZ technology Ltd
Relationship Type: UK Responsible Person
Address: Stirling House Cambridge Innovation Park, Denny End Road, Waterbeach
Cambridge, Cambridgeshire, United Kingdom
Postcode: CB25 9QE

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About this record

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA) is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 85747. The device is manufactured by InnaK Diagnostics, Inc. from United States, classified as In Vitro Diagnostic Device. The authorized representative in the UK is NPZ technology Ltd.

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