Manufacturer's By Device SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay rapid-SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit fluorescent immunoassay rapid

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Acro Biotech Inc.4650 Arrow Highway Suite D-6

Montclair
CA 91763

United States
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
04/26/202113601
CITEST DIAGNOSTICS INC170-422 Richards Street Vancouver BC
V6B 2Z4 Canada
Vancouver
V6B 2Z4

Canada
UK RepMed Ltd.Wey Court West Union Road
Farnham Surrey
Farnham
GU9 7PT

England United Kingdom
08/11/202116644
Hangzhou Alltest Biotech Co Ltd#550 Yinhai Street Hangzhou Economic & Technological Development Area

Hangzhou
310018

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202212580
LumiraDx UK Ltd.Unit 1 Block 5 Dumyat Business Park
Bond Street
Alloa
FK102PB

United Kingdom





05/06/20209941
NewScen Coast Bio-Pharmaceutical Co. Ltd.No. 65 6th Street Tianjin TEDA

Tianjin
300457

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/28/202210590