Manufacturer's By Device Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)-Opiate/opiate metabolite IVD kit enzyme immunoassay (EIA)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Beckman Coulter Inc.250 South Kraemer Boulevard

Brea
California -

United States
Beckman Coulter UK LtdOakley Court Kingsmead Busines sPark
London Rd
High Wycombe
Bucks HP11 1JU

United Kingdom
04/19/202214139
Glenbio Ltd.10 Kilbegs Road

Antrim
Co. Antrim BT41 4NN

Northern Ireland United Kingdom





08/28/20157208
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
Ortho-Clinical Diagnostics Inc.100 Indigo Creek Drive

Rochester
New York 14626

United States
Ortho-Clinical DiagnosticsFelindre Meadows Pencoed

Bridgend
CF35 5PZ

Wales United Kingdom
12/04/20157248
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
Siemens Healthcare Diagnostics Inc511 Benedict Avenue

Tarrytown
NY 10591

United States
Siemens Healthcare Diagnostics LimitedPark View Watchmoor Park

Surrey
Camberley GU15 3YL

England United Kingdom
04/01/201534