Manufacturer's Devices - Progenika Biopharma S.A.

Address:




Ibaizabal bidea Edificio 504 Parque Tecnologico de Bizkaia



Bizkaia

48160

Spain


Authorised Representative/ UK Responsible Person
Name: Grifols UK Limited
Address:

3980-3990 Enterprise Cambridge Research Park

Beach Drive

Waterbeach

CB25 9PE

England United Kingdom




Code/Term Type
Multiple blood group genotyping IVD kit microarrayMultiple blood group genotyping IVD kit microarrayIVD Annex II List A
Multiple blood group genotyping IVD controlMultiple blood group genotyping IVD controlIVD Annex II List A
TNF-alpha inhibitor therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)TNF-alpha inhibitor therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Rituximab antibody IVD kit enzyme immunoassay (EIA)Rituximab antibody IVD kit enzyme immunoassay (EIA)IVD General
Ustekinumab therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Ustekinumab therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Rituximab therapeutic drug monitoring IVD kit enzyme immunosassay (EIA)Rituximab therapeutic drug monitoring IVD kit enzyme immunosassay (EIA)IVD General
Vedolizumab therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)Vedolizumab therapeutic drug monitoring IVD kit enzyme immunoassay (EIA)IVD General
Ustekinumab antibody IVD kit enzyme immunoassay (EIA)Ustekinumab antibody IVD kit enzyme immunoassay (EIA)IVD General
Vedolizumab antibody IVD kit enzyme immunoassay (EIA)Vedolizumab antibody IVD kit enzyme immunoassay (EIA)IVD General
Alpha-1-antitrypsin deficiency IVD kit nucleic acid technique (NAT)Alpha-1-antitrypsin deficiency IVD kit nucleic acid technique (NAT)Class C
TNF-alpha inhibitor therapeutic drug monitoring IVD kit rapid ICT clinicalTNF-alpha inhibitor therapeutic drug monitoring IVD kit rapid ICT clinicalClass B – Self-testing or Near-patient Testing
TNF-alpha inhibitor therapeutic drug monitoring IVD kit rapid ICT clinicalTNF-alpha inhibitor therapeutic drug monitoring IVD kit rapid ICT clinicalIVD General
TNF-alpha inhibitor antibody IVD kit enzyme immunoassay (EIA)TNF-alpha inhibitor antibody IVD kit enzyme immunoassay (EIA)IVD General