948 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class B
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Testosterone (CLIA)、Testosterone Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Luteinizing Hormone（CLIA）、LH Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Total β Human Chorionic Gonadotrophin（CLIA）、Total β HCG Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Follicle Stimulating Hormone（CLIA）、FSH Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Optilite® Alpha-2-Macroglobulin Urine Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·The Binding Site Group Ltd·2 devices
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
Optilite® IgA2 Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·The Binding Site Group Ltd·2 devices
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·3 devices
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·2 devices
iFlash-ALD
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices
iFlash-Renin
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices
iFlash-Osteocalcin
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·3 devices
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·3 devices
i-Tracker Anti-Etanercept
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·BIOSYNEX·1 device
i-Tracker Etanercept
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·BIOSYNEX·1 device
i-Tracker Anti-Infliximab Total Ab
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·BIOSYNEX·1 device
i-Tracker Anti-Adalimumab Total Ab
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·BIOSYNEX·1 device