BEUDAMED
    537 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: Eu Ivd Class C ×

    HbA1c Advanced

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

    sthemO CK Prest

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

    STA® - Apixaban Control

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

    Optilite® Freelite Mx™ Lambda Free Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

    Optilite® Hevylite® IgG Lambda Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

    HbA1c

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

    STA® - Apixaban Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

    C-Reactive Protein Kit (Immunoturbidimetric Method)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Zybio Inc.·12 devices

    High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）、HS-CRP Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

    Optilite® Hevylite® IgM Kappa Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

    Optilite® Hevylite® IgM Lambda Kit

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·The Binding Site Group Ltd·2 devices

    Access AFP (300 & 600 Test Kit)

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·2 devices

    Control Serum Level 2

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Ireland Inc.·1 device

    Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)、FER Calibrator

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

    CK-MB

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

    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

    RIDA®GENE Bacterial Stool Panel I

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·R-Biopharm AG·3 devices

    RIDA®GENE Bacterial Stool Panel

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·R-Biopharm AG·3 devices

    RPR-DAT

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·DIESSE Diagnostica Senese S.p.A·1 device

    Newbio TPHA 100

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Newmarket Biomedical Ltd·6 devices