108 results
·
7ms
·
Sources: EU EUDAMED, US FDA
iCan CGM
Device
EU MDR
·
Eu Md Class 2b
·Changsha Sinocare Inc.·On the market·19 countries
Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
iFlash-Cardiolipin IgM
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
Cardiolipin IgM Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
Mycoplasma pneumoniae IgM /Chlamydia pneumoniae IgM Antibody Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Accuracy Biotechnology Co.,Ltd.·1 device
HEV IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
HAV IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
Salmonella IgM FIA Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
MP IgM FIA Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
RF-IgM FIA Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
EB EA IgM Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
EB VCA IgM Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
M. Pneumoniae IgM Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
HSV-2 IgM Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
HSV-1 IgM Control
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·SHENZHEN YHLO BIOTECH CO., LTD.·1 device
COVID-19 IgM/IgG Rapid Test / SARS-CoV-2 IgM/IgG Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device
Leptospira IgG/IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
Filariasis IgG/IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
Enterovirus 71 IgM Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device