United Kingdom MHRA device registration 90114

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

United Kingdom flagUnited Kingdom·In Vitro Diagnostic Device·Aikang Diagnostics Co Ltd.·Registered Jul 22, 2021
Registration details
Device ID
90114
Date Registered
Jul 22, 2021
Last Updated
Dec 22, 2022
Device classification
Device Type
In Vitro Diagnostic Device
Devices
SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical
Type
IVD General
Manufacturer
Address
501 Building 1&3 Hongxin Industrial Park Guanguang Road 1303 Guanlan Longhua District
Guangdong, Shenzhen, China
Created Date
Jul 22, 2021
Authorized Representative
Relationship Type
UK Responsible Person
Address
2 The Drift
Thurston, Suffolk, United Kingdom
Postcode: IP31 3RT
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About this record

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 90114. The device is manufactured by Aikang Diagnostics Co Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Medimap Ltd.

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