Manufacturer's Devices - Abbott Rapid Diagnostics Jena GmbH

Address:




Orlaweg 1



Jena

Thuringia 07743

Germany


Authorised Representative/ UK Responsible Person
Name: Unipath Limited (trading as Alere International)
Address:

Clearblue Innovation Centre Priory Business Park

Stannard Way

Bedford

Bedfordshire MK44 3UP

England United Kingdom




Code/Term Type
SARS-CoV-2 antigen IVD kit rapid ICT clinicalSARS-CoV-2 antigen IVD kit rapid ICT clinicalIVD Devices for Self-Testing
SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalSARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD kit rapid ICT clinicalIVD General
Clinical laboratory analyser/instrument control unit IVDClinical laboratory analyser/instrument control unit IVDIVD General
Optical instrument performance standard calibrator/control IVD reusableOptical instrument performance standard calibrator/control IVD reusableIVD General
CD4 cell marker IVD kit fluorescent immunoassay rapidCD4 cell marker IVD kit fluorescent immunoassay rapidIVD General
SARS-CoV-2 antigen IVD controlSARS-CoV-2 antigen IVD controlIVD General
SARS-CoV-2 antigen IVD kit rapid ICT clinicalSARS-CoV-2 antigen IVD kit rapid ICT clinicalIVD General