46 results
·
9ms
·
Sources: EU EUDAMED, US FDA
RIDASCREEN® α1-Antitrypsin
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·2 devices
RIDA qLine® Allergy
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·27 devices
RIDA®QUICK Helicobacter
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·2 devices
RIDA®CHIP FoodGuide
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·3 devices
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
small dense LDL-Calibrator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·1 device
Follicle-stimulating Hormone (FSH) (Light-initiated Chemiluminescence Immunoassay, LiCA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Chemclin Diagnostics Co., Ltd.·4 devices
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