46 results · 9ms · Sources: EU EUDAMED, US FDA

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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