961 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class B
×
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
Optilite® C2 Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·The Binding Site Group Ltd·2 devices
Optilite® IgM CSF Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·The Binding Site Group Ltd·2 devices
Optilite® C1q Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·The Binding Site Group Ltd·2 devices
STA® - Deficient IX
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Diagnostica Stago·1 device
RIDASCREEN® α1-Antitrypsin
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·2 devices
Total IgE (CLIA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Maccura Biotechnology Co., Ltd. ·4 devices
Adrenocorticotropic hormone(CLIA)、ACTH Calibrators、ACTH Control
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices
RIDASCREEN® Adenovirus
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·5 devices
RIDASCREEN® Rotavirus
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·R-Biopharm AG·5 devices
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·3 devices
Progesterone（CLIA）、Progesterone Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
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