13 results · 16ms · 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

PSA total IRMA KIT

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·1 device

PSA free IRMA KIT

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·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

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