46 results
·
9ms
·
Sources: EU EUDAMED, US FDA
CRP Calibration Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·1 device
Ferritin Calibration Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·1 device
sTfR Calibration Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·1 device
α1-Microglobulin Calibrator Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·1 device
small dense LDL-Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·1 device
IDS ANCA/GBM Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS ANA Screen Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
IDS-iSYS 1,25 VitDXp Control Set
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·1 device
mAbXmise – Anti-drug antibodies quantification Kit multiplex ANTI-Infliximab & ANTI-Adalimumab
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Promise proteomics·1 device
sthemO Pool Norm
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
sthemO XI
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
sthemO FVII QC
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
sthemO VII
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
STA® - FM Calibrator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
STA® - Deficient IX
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
mAbXmise – Monoclonal antibodies quantification Kit Eculizumab or Ravulizumab
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Promise proteomics·1 device
mAbXmise – Monoclonal antibody quantification Kit Emicizumab
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Promise proteomics·1 device
mAbXmise – Monoclonal antibodies quantification Kit Multiplex Infliximab, Adalimumab, Obinutuzumab, Secukinumab, Tocilizumab, Ustekinumab, Vedolizumab
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Promise proteomics·1 device
sthemO PS clot
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
sthemO FDP QC 1&2
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device