43 results · 17ms · Sources: EU EUDAMED, US FDA

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Thyroglobulin(CLIA)、Thyroglobulin Calibrators

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·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

sthemO FDP cal

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO IX

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO VIII

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device