Manufacturer's By Device Influenza A/B virus nucleic acid IVD kit nucleic acid technique (NAT)-Influenza A/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 Diagnostics Scarborough Inc.10 Southgate Rd

Scarborough
Maine 04074

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

England United Kingdom
07/08/202115830
altona Diagnostics GmbHaltona Diagnostics GmbH Mörkenstr. 12

22767 Hamburg
22767

Germany
altona diagnostics UK LtdNo 1 St Pauls Square

Liverpool
L3 9SJ

England United Kingdom
05/07/202114304
bioMérieux S.AbioMérieux S.A

Marcy L'Etoile (69280)
69280

France
bioMérieux UK LtdChineham Gate Crockford Lane

Basingstoke
Hampshire RG24 8NA

England United Kingdom
03/30/202113038
Guangzhou Pluslife Biotech Co. Ltd.Room 402 6 Lianhuayan Road Huangpu District Guangzhou

Guangdong Province
510700

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
08/17/202225539
Merlin Biomedical (Xiamen) Co. Ltd.4th Floor Building B3 2054 West Wengjiao Rd.

Haicang
Xiamen 361028

China
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/07/202113061
Quidel Corporation2005 East State Street Suite 100

Athens OH
45701

United States
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
02/25/202223263
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
Sansure Biotech Inc.No. 680 Lusong Road Yuelu District

Changsha
Hunan Province 410205

China
Obelis UK LtdSandford Gate East Point Business Park

Oxford
OX4 6LB

England United Kingdom
09/28/202117610
Trentron Biomedical Ltd.(Building A) 35F. No.99 Sec.1 Xintai 5th Road

New taipei city
Xizhi District 22175

Taiwan
Advena LtdPure Offices Plato Close

Warwick
CV34 6WE

England United Kingdom
07/06/202218086