Manufacturer's By Device SARS-CoV-2 neutralizing antibody IVD kit chemiluminescent immunoassay-SARS-CoV-2 neutralizing antibody IVD kit chemiluminescent immunoassay

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Autobio Diagnostics Co. LtdNo. 87 Jingbei Yi Road National Eco & Tech Development Area

Zhengzhou
450016

China
Chirus LimitedGreenhill House 26 Greenhill Crescent
Watford Business Park
Watford
Hertfordshire WD18 8JA

England United Kingdom
09/01/202116792
Beijing Hotgen Biotech Co Ltd9th Building No 9 Tianfu Street Biomedical Base Daxing District

Beijing
102600

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202212377
Guangzhou Wondfo Biotech Co. Ltd.No.8 Lizhishan Road Science City Luogang District

Guangzhou
510663

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
03/07/202112536
Mico BioMed Co. Ltd.3rd and 4th floor 54 changeop-ro Sujeng-gu Seongnam-si Gyeonggi do

Sujeng-gu Seongnam-si
13449

South Korea
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/01/202225408
Prometheus Bio Inc2nd floor No. 3 8th Street Qiantang Area

Hangzhou Zhejiang
310018

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/29/202114185
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
Shenzhen New Industries Biomedical Engineering Co. Ltd.No.23 Jinxiu East Road Pingshan District

Shenzhen
518122

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202216793
SHENZHEN YHLO BIOTECH CO. LTD.Building 1 YHLO Biopark Baolong 2nd Road Baolong Subdistrict Longgang District

Shenzhen Guangdong
518116

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202216153