Manufacturer's By Device Ethyl glucuronide (EtG) IVD control-Ethyl glucuronide (EtG) IVD control

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
ARK Diagnostics Inc.48089 Fremont Blvd

Fremont
California 94538

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
11/08/202119952
Biochemical Diagnostics Inc180 Heartland Blvd.

Edgewood
New York 11779

United States
Advena LtdPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom
12/29/202121583
Immunalysis Corporation829 Towne Center Drive

Pomona
California 91767

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

England United Kingdom
11/01/202119091
Lin-Zhi International Inc.2945 Oakmead Village Court

Santa Clara
California 95051

United States
UKCApartner4U Limited7 CAMPION WAY

BINGHAM NOTTINGHAM
NG13 8 TR

England United Kingdom
10/15/202118294
Microgenics Corporation46500 Kato Road

Fremont
California CA 94538

United States
Thermo Fisher Diagnostics Ltd.16 Shenley Pavillions Chalkdell Drive
Shenley Wood
Milton Keynes
MK5 6LB

England United Kingdom
07/14/202225266
UTAK Laboratories Inc.25020 Avenue Tibbitts Valencia

CA
91355

United States
IVDeology UKRP Ltd22-23 The Joiners Shop Historic Dockyard
Chatham
Rochester
Kent ME4 4TZ

England United Kingdom
07/15/202115982