BEUDAMED
    1,816 results · 33ms · Sources: EU EUDAMED, US FDA

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 CISH PHARMDX KIT

    QC Solution

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Genrui Biotech Inc.·1 device

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·LOTRAFILCON A & B SOFT CONTACT LENSES

    sthemO FVII QC

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

    Access AMH QC

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·IMMUNOTECH SAS ·1 device

    Access BNP QC

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

    Access BNP QC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    Access SHBG QC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    HAV Ab QC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    Access CEA QC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    Access Ostase QC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

    Access SHBG QC

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

    Access Ostase QC

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

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-AB-EBK PLUS ASSAY

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-AB-COREK PLUS ASSAY

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·G4 Insulin Pump with Dexcom G4 Platinum CGM System

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-EBK-PLUS

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY