Manufacturer's By Device Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical-Beta-haemolytic Group A Streptococcus antigen IVD kit rapid ICT clinical

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Medical Co. Ltd.357 Matsuhidai Matsudo-shi

Chiba
270-2214

Japan
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
04/19/202113507
Abbott Diagnostics Scarborough Inc.10 Southgate Rd

Scarborough
Maine 04074

United States
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
07/08/202115830
ABON Biopharm (Hangzhou) Co. Ltd.#198 12th Street East Hangzhou Economic & Technological Development Zone

Hangzhou
Zhejiang 310018

China
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
04/19/202113506
Atlas Medical GmbHLudwig-Erhard-Ring 3 15827 Blankenfelde-Mahlow

Berlin
15827

Germany
Atlas MedicalWilliam James House Cowley Road

Cambridge
CB4 0WX

United Kingdom
04/21/202113630
Becton Dickinson and Company (BD)7 Loveton Circle

Sparks
Maryland 21152

United States
Becton Dickinson U.K. Limited1030 Eskdale Road Winnersh Triangle Wokingham

Winnersh
RG41 5TS

England United Kingdom
09/09/202117321
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom





03/02/20209656
Biorex Diagnostics LtdAntrim Technology Park

Antrim
BT41 1QS

Northern Ireland United Kingdom





05/01/20157201
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
DIALAB GmbHIZ NOE-Sued Hondastrasse
Objekt M55 IZ NOE-Sued
Wr. Neudorf
2351

Austria
Alpha Laboratories LtdUnit 40 Parham Drive

Eastleigh
Hampshire SO50 4NU

United Kingdom
11/12/202119029
Fortress Diagnostics LimitedTechnology Park Belfast Road
Muckamore
Antrim
County Antrim BT41 1QS

Northern Ireland United Kingdom





12/15/20157210
FUJIFILM Corporation26-30 Nishiazabu 2-chome
Minato-ku
Tokyo
106-8620

Japan
Fujifilm UK LimitedFujifilm House Whitbread Way

Bedford
MK42 0ZE

England United Kingdom
04/12/202218937
Getein Biotech Inc.No.9 Bofu Road Luhe District

Nanjing
211505

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
02/09/202222849
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
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
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
HUMAN Gesellschaft für Biochemica und Diagnostica mbHMax-Planck-Ring 21

Wiesbaden
65205

Germany
Cambridge Life Sciences Ltd14 St. Thomas' Place

Ely
Cambridgeshire CB7 4EX

England United Kingdom
12/22/202121401
Innovacon Inc9975 Summer Ridge Road

San Diego
California 92121

United States
Unipath Limited (trading as Alere International)Clearblue Innovation Centre Priory Business Park
Stannard Way
Bedford
Bedfordshire MK44 3UP

England United Kingdom
12/02/202120262
Nanjing Liming Bio-Products Co. Ltd.No.12 Huayuan Road

Nanjing Jiangsu
210042

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/09/202011119
Prestige Diagnostics U.K. Ltd40 Ballymena Business Centre Galgorm

Ballymena
County Antrim BT42 1FL

Northern Ireland United Kingdom





07/21/20157207
PRIMA Lab SAVia Antonio Monti
Balerna
Balerna
Mendrisio 6828

Switzerland
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
08/05/202115986
Pro-Lab Diagnostics3 Bassendale Road

Bromborough
Wirral CH62 3QL

England United Kingdom





01/16/2004958
Quidel Corporation10165 McKellar Ct.

San Diego CA
92121

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
02/25/202223264
Rapid Labs LtdUnit 2 & 2a Hall Farm Business Centre

Colchester
Essex CO7 8SD

United Kingdom





11/29/20199366
SAFECARE BIOTECH (HANGZHOU) CO. LTD.Building 2/203 No. 18 Haishu Rd.
Cangqian Sub-district Yuhang District
Hangzhou
311121

China
SHARE INFO LTD3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS

England United Kingdom
01/23/202222245
SD Biosensor Inc.C-4th&5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu Suwon-si Gyeonggi-do 16690 Republic of Korea

Suwon-si
16690

South Korea
MT Promedt Consulting LtdBeaver House 23-38 Hythe Bridge Street

Oxford
OX1 2EP

England United Kingdom
05/11/202114605
Sekisui Diagnostics LLC6659 Top Gun Street

San Diego
CA 92121

United States
Sekisui Diagnostics (UK) LtdSekisui Diagnostics (UK) Ltd Liphook Way
Allington
Maidstone
Kent ME19 0LQ

England United Kingdom
01/11/202221242
Shenzhen JetMay Care LimitedDistrict 02 1F & 3F Block A Haikexing Sinovac Strategic Emerging Industrial Park Pingshan District

Shenzhen Guangdong
518118

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/14/202210391
Shenzhen Uni-medica Technology Co. LtdRoom 202 Block 6th LiuXian Culture Park XiLi Town NanShan District

Shenzhen
Guangdong Province 518000

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/17/202225540
Vedalabrue de l'Expansion ZAT du Londeau Cerisé rue de l'Expansion ZAT du Londeau Cerisé

ALENCON CEDEX
61006

France
First Health Products LtdOpTIC Technology Centre Glyndr University St Asaph Business Park

St Asaph
Denbighshire LL17 0JD

United Kingdom
10/14/202118160
W.H.P.M. Bioresearch & Technology Co. Ltd.No.2 Zhongxin Street Louzizhuang Jinzhanxiang Chaoyang District

Beijing
100018

China
lotus global co ltd23 Maine Street

Reading
Reading RG2 6AG

England United Kingdom
04/13/202213234