Manufacturer's By Device SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay-SARS-CoV-2 immunoglobulin M (IgM) antibody IVD kit chemiluminescent immunoassay

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Ireland Diagnostics DivisionFinisklin Business Park

Sligo
n/a

Ireland
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202212578
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
Beckman Coulter Inc.250 South Kraemer Boulevard

Brea
California -

United States
Beckman Coulter UK LtdOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU

United Kingdom
04/19/202214139
DiaSorin S.p.A.DiaSorin S.p.A.
Via Crescentino SALUGGIA
VC
Piemonte 13040

Italy
DiaSorin S.p.A. UK BranchCentral Road

Dartford
DA1 5LR

United Kingdom
04/27/202113991
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