United Kingdom MHRA device registration 85779

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

United Kingdom·In Vitro Diagnostic Device·Acro Diagnostics Co., Ltd.·Registered Nov 26, 2024

Registration details

Device ID: 85779
MHRA Reference Number: 85779
Date Registered: Nov 26, 2024
Last Updated: May 26, 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: Acro Diagnostics Co., Ltd.
Address: Room 8106 and 8107, Floor1, Building3, Yongchang Industrial Park No.3 Yongchang North Road, BDA
Beijing, China
Created Date: Jun 17, 2021

Authorized Representative

Name: KINGSMEAD SERVICE LIMITED
Relationship Type: UK Responsible Person
Address: 19 MEZZANINE FLOOR 19-21 CRAWFORD STREET
London, England, United Kingdom
Postcode: W1H 1PJ

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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 85779. The device is manufactured by Acro Diagnostics Co., Ltd. from China, classified as In Vitro Diagnostic Device. The authorized representative in the UK is KINGSMEAD SERVICE LIMITED.

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