113 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class C
×
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
Access Hybritech PSA (Sample Diluent)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA (Reagent Pack)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·2 devices
Access Hybritech free PSA (Reagent Pack)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·2 devices
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 Liquid Anti-Xa
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·32 countries
HemosIL UF Heparin Controls
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL LMW Heparin Controls
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Apixaban Calibrators
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Special Test Control Level 2
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·32 countries
HemosIL Dabigatran Controls
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Dabigatran Calibrators
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Direct Thrombin Inhibitor Assay
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Rivaroxaban Controls
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Rivaroxaban Calibrators
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL Apixaban Controls
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·31 countries
HemosIL D-Dimer HS
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·32 countries
HemosIL D-Dimer Controls
Device
EU IVDR
·
Eu Ivd Class C
·Instrumentation Laboratory Company·On the market·32 countries