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.9500 7th Street Unit M

Rancho Cucamonga
CA 91730

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
Guangdong Wesail Biotech Co. LtdRoom 403 Building 1 1 Taoyuan RD Songshan Lake Science and Technology Industrial Park Songshan Lake

Dongguan Guangdong
523808

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/29/202011317
Hangzhou Deangel Biological Engineering Co. Ltd.Jinxing Cun Yuhang Community Yuhang District (Futuer Sci-Tech City)

Hangzhou Zhejiang
311121

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/19/202011125
Lansion Biotechnology Co. Ltd.No.2 Qiande Road Jiangning District Nanjing China

Nanjing
211100

China
PureUKCA Ltd59 St. Martin's Lane

London
Middlesex WC2N 4JS

England United Kingdom
11/05/202119721
LumiraDx UK Ltd.Unit 1 Block 5 Dumyat Business Park
Bond Street
Alloa
FK102PB

United Kingdom





12/31/99999941
Shenzhen Kingfocus Biomedical Engineering Co. Ltd.10F Building B No.71-2 Xintian Avenue Xintian Community Fuhai Street Bao'an District

Shenzhen City Guangdong
518103

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
06/18/202010192