BEUDAMED
    5,135 results · 43ms · Sources: EU EUDAMED, US FDA

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    EZ-PSA Professional PSA Test

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Biomerica, Inc.·1 device

    PSB

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·EM EXACT, S.A.·8 devices

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

    IntelliVue Patient Monitor MX500, SW Rev. K.20

    FDA registration
    Philips Medizin Systeme Boeblingen GmbH·5 products·🇩🇪 Germany

    IntelliVue Patient Monitor MX500, SW Rev. K.20

    FDA registration
    Philips Electronics Ltd·5 products·🇨🇦 Canada

    Klic10 Blood Collection Accessories

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·1 device

    Ultra-Low PSA Control (UL PSA Control)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·1 device

    High Myopia Risk Prediction Gene Test Kit (Gene sequencing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

    High Myopia Risk Prediction Gene Test Kit (Gene sequencing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

    High Myopia Risk Prediction Gene Test Kit (Gene sequencing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

    High Myopia Risk Prediction Gene Test Kit (Gene sequencing)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device

    Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·PSI Gene Technology Co.,Ltd.·1 device