Manufacturer's By Device Ethanol (ETOH) IVD kit enzyme spectrophotometry-Ethanol (ETOH) IVD kit enzyme spectrophotometry

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
BRAHMS GmbHNeuendorfstr. 25

Hennigsdorf
16761

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

England United Kingdom
07/11/202225259
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
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
Randox Laboratories LimitedArdmore 55 The Diamond Road

Crumlin
County Antrim BT29 4QY

Northern Ireland United Kingdom





05/30/201881
SEKISUI DIAGNOSTICS P.E.I. Inc.70 Watts Avenue

Charlottetown
Prince Edward Island C1E 2B9

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

England United Kingdom
01/20/202221370
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