43 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Ultra-Low PSA Control (UL PSA Control)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Randox Laboratories Limited·1 device
Total Prostate Specific Antigen(CLIA)、Total PSA Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Access Hybritech PSA (QC)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA (Calibrator)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech free PSA (QC)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech free PSA (Calibrators)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Free Prostate Specific Antigen (CLIA)、Free PSA Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·4 devices
HemosIL Heparin
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Heparin Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Apixaban Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Special Test Control Level 2
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Dabigatran Controls
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Dabigatran Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Direct Thrombin Inhibitor Assay
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL ISI Calibrate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL INR Validate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Factor VIII deficient plasma
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Factor IX deficient plasma
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device
HemosIL Factor VIII deficient plasma
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·1 device