Manufacturer's By Device SARS-CoV-2 nucleic acid IVD, control-SARS-CoV-2 nucleic acid IVD, control

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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
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
Microbiologics INC200 Cooper Avenue North

Saint Cloud
Minnesota 56303

United States
BioConnections LtdUnit 10 Brindley Court Victoria Business Park

Knypersley
Staffordshire ST8 7PP

England United Kingdom
03/24/202112852
National Institute for Biological Standards and Control (NIBSC)Blanche Lane South Mimms

Potters Bar
Hertfordshire EN6 3QG

United Kingdom





02/07/20172
OptiGene LimitedUnit 5 Blatchford Rd

Horsham
West Sussex RH13 5QR

United Kingdom





12/31/999910323
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
10/15/202118086