15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
FDA 510(k)
FDA Class 2
·Cardiovascular
Gastric proteogen 2 (PG II) Detection Kit(CLIA)
Device
EU IVDD
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Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
Gastric proteogen 1 (PG I) Detection Kit(CLIA)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
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
Gastric proteogen 2 (PG II) Detection Kit(CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
Gastric proteogen 1 (PG I) Detection Kit(CLIA)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·1 device
Alanine Aminotransferase kit (IFCC Method)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
One Step Methcathinone (MCAT) Test Kit (Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Methamphetamine (MET) Test Kit (Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Cocaine (COC) Test Kit (Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Amphetamine (AMP) Test Kit(Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Morphine (MOP) Test Kit(Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Methylenedioxymethamphetamine (MDMA) Test Kit(Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Marijuana (THC) Test Kit(Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device
One Step Ketamine (KET) Test Kit(Hair) (Colloidal Gold )
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd·1 device