Manufacturer's By Device Influenza A/B virus antigen IVD kit rapid ICT clinical-Influenza A/B virus antigen IVD kit rapid ICT clinical

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Diagnostics Korea Inc.65
Borahagal-Ro Giheung-Gu
Gyeonggi-Do
Yongin-Si 17099

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

England United Kingdom
03/30/202113027
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
ACON Biotech (Hangzhou) Co LtNo 210 Zhenzhong Road West Lake District

Hangzhou
310030

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202211766
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
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO. LTD.4th Floor D-1# Zone Pearl Industrial Park 106 Innovation Avenue High-Tech Development Zone

Hefei
Anhui 230088

China
KINGSMEAD SERVICE LIMITED19 MEZZANINE FLOOR 19-21 CRAWFORD STREET

London
W1H 1PJ

England United Kingdom
06/28/202225076
Asan Pharmaceutical Co. Ltd.122-26 Gieopdanji-ro Gongdo-eup

Anseong-si
Gyeonggi-do 17551

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

Oxford
OX1 2EP

England United Kingdom
07/12/202225236
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
Bioantibody Biotechnology Co. Ltd.Room 903/905 Building C6 9 Weidi Road Nanjing

Jiangsu Province
210046

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
07/25/202225380
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom





03/02/20209656
Biopanda Reagents Ltd.Unit 14 Carrowreagh Business Park Carrowreagh Road
Dundonald
Belfast
Down BT16 1QQ

Northern Ireland United Kingdom





03/02/20209656
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
Coris BioConceptScience Park CREALYS Rue Jean Sonet 4A

Gembloux
5032

Belgium
BioConnections LtdUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP

England United Kingdom
07/09/202115819
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
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
Inzek International Trading BVVissenstraat 32

Apeldoorn
Provincie Gelderland 7324 AL

Netherlands
Dawn Asset Management LimitedKalamu House Coldbath Square

London
EC1R 5HL

England United Kingdom
04/20/202216090
Jiangsu Accuracy Biotechnology Co. Ltd.No. 8 Shengchang West Road Danyang Development Zone Danyang

Jiangsu Province
212300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
01/16/202218898
Meridian Bioscience Inc.3471 River Hills Drive

Cincinnati
OH 45244

United States
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
09/08/202117346
Merlin Biomedical (Xiamen) Co. Ltd.4th Floor Building B3 2054 West Wengjiao Rd.

Haicang
Xiamen 361028

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/07/202113061
Pro-Lab Diagnostics3 Bassendale Road

Bromborough
Wirral CH62 3QL

England United Kingdom





01/16/2004958
Rapid Labs LtdUnit 2 & 2a Hall Farm Business Centre

Colchester
Essex CO7 8SD

United Kingdom





11/29/20199366
Remel Inc12076 Santa Fe Trail Drive

Lenexa
Kansas 66215

United States
Oxoid LimitedWade Road

Basingstoke
RG24 8PW

England United Kingdom
11/15/202119041
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
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
Shanghai Homelabs Medical Co. LtdRoom 301 No. 5 Lane 88 Shengrong Road China (Shanghai) Pilot Free Trade Zone.

Shanghai
201203

China
NPZ technology LtdStirling House Cambridge Innovation Park
Denny End Road Waterbeach
Cambridge
Cambridgeshire CB25 9QE

United Kingdom
05/27/202224775
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
Sugentech Inc.721-26 Jeongjungyeonje-ro Osong-eup Heungdeok-gu

Cheongju-si
Chungcheongbuk-do 28161

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

Oxford
OX1 2EP

England United Kingdom
07/07/202115729
Tianjin Bioscience Diagnostic Technology Co. Ltd.Building 14 INT Medical Device Industrial Park No. 16 Wujing Road Dongli Economic and T&D Zone

Tianjin
300300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
07/22/202225375
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