Manufacturer's By Device SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT)-SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT)

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Diagnostics for the Real World LtdDiagnostics for the Real World Ltd 845 Embedded Way suite 150

San Jose
CA 95138

United States
Diagnostics For The Real World (Europe) LtdSuite 12 Science Village
Chesterford Research Park
Little Chesterford
Essex CB10 1XL

United Kingdom
04/05/202212398
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
Kangmei Tianhong Biotech (Beijing) Co. Ltd. #16 No.1 Gaolizhang Road

Haidian Beijing
100095

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
01/10/202221131
KH Medical Co. Ltd.201 Jinwiseo-ro Jinwi-myeon

Pyeongtaek-si
Gyeonggi-do 17712

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

Oxford
OX1 2EP

England United Kingdom
05/07/202114540
Nonacus LimitedBioHub Birmingham Research Park 97 Vincent Drive

Birmingham
West Midlands B15 2SQ

United Kingdom





12/07/202011077
R-Biopharm AGR-Biopharm AG An der neuen Bergstrasse 17

Darmstadt
64297

Germany
R-Biopharm Rhone LtdMazars 30 Old Bailey

London
EC4M 7AU

England United Kingdom
11/15/202120085
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