Manufacturer's By Device Opiate/opiate metabolite IVD kit rapid ICT clinical-Opiate/opiate metabolite IVD kit rapid ICT clinical

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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
Assure Tech. (Hangzhou) Co. Ltd.Building 4 No 1418-50 Moganshan Road Gongshu District

Zheijiang
Hangzhou 310011

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
05/13/202224626
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
Bio-Rad Laboratories Inc. Clinical Systems Division (CSD)4000 Alfred Nobel Drive

Hercules
94547

United States
BIO-RAD LABORATORIES LIMITEDThe Junction 3rd And 4th Floor Station Road Watford United Kingdom WD17 1ET

WATFORD
Hertfordshire wd17 1et

England United Kingdom
05/13/202221626
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
Matrix Diagnostics LtdMatrix Diagnostics Ltd Unit 9 Merdian Business Park Fleming Road Waltham Abbey
Waltham Abbey
Waltham Abbey
Essex EN9 3BZ

United Kingdom





12/04/20199393
Prometheus Bio Inc2nd floor No. 3 8th Street Qiantang Area

Hangzhou Zhejiang
310018

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
04/29/202114185
Siemens Healthcare Diagnostics Inc500 GBC Drive Mailstop 514
P O Box 6101
Newark
DE 19714

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201532