Manufacturer's By Device Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)-Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT) Conformity Assessment Certificate Expired, Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Abbott Molecular Inc.1350 E. Touhy Ave

Des Plaines IL
Illinois 60018

United States
Abbott Laboratories LimitedAbbott House Vanwall Business Park Vanwall Road

Maidenhead
Berkshire SL64XE

England United Kingdom
04/28/202213024
Anatolia Tan ve Biyoteknoloji Ürünleri Ar-Ge San. ve Tic. AHasanpasa Mah. Beydagi Sk
No: 1-9 H
Istanbul
Sultanbeyli 34920

Turkey
Launch Diagnostics LimitedAsh House Ash Road New Ash Green

Longfield
Kent DA3 8JD

United Kingdom
04/28/202114050
BIONEER Corporation8-11 Munpyeongseo-ro

Daedeok-gu
Daejeon 34302

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

Oxford
OX1 2EP

England United Kingdom
01/18/202213753
Cepheid ABRöntgenvägen 5

Solna
171 54

Sweden
Cepheid UK LtdOakley Court Kingsmead Business Park
Frederick Place
High Wycombe
HP11 1JU

England United Kingdom
08/02/202112004
Daan Gene Co. Ltd.No. 19 Xiangshan Road Science ParkHigh & New Technology Development District

Guangzhou
Guangdong 510665

China
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
04/15/202223572
GeneProof a.s.101/119 Dolní Heršpice
Vídeská Brno
Brno-msto
Jihomoravský kraj 619 00

Czechia
Pathway Diagnostics LtdEclipse House Curtis Road

Dorking
Surrey RH4 1EJ

United Kingdom
05/19/202224319
Hologic Inc.10210 Genetic Center Drive

San Diego
CA 92121

United States
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom
03/11/201669
Hologic Ltd.Heron House 6 The Oaks Business Park Crewe Road Wythenshawe

Manchester
Lancashire M23 9HZ

England United Kingdom





11/09/201768
QIAGEN GmbHQIAGEn GmbH
Qiagen Str. 1 Hilden
Mettmann
Düsseldorf 40724

Germany
QIAGEN Manchester Ltd.QIAGEN Manchester Ltd. Citylabs 2.0
200 Hathersage Road
Manchester
M13 0BH

England United Kingdom
03/19/202112724
Roche Molecular Systems Inc.Roche Molecular Systems Inc. 1080 US Highway 202 South

Branchburg
NJ 08876

United States
Roche Diagnostics LimitedRoche Diagnostics Limited Charles Avenue

Burgess Hill
West Sussex RH15 9RY

United Kingdom
04/26/202113715