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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

    Inion Instruments

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Inion Oy·8 devices

    Reagent, Coronavirus Serological

    FDA classification
    FDA Not Classified ·Reagent, Coronavirus Serological

    Igm, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igm, Antigen, Antiserum, Control

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    FDA Pre-Market Approval
    FDA Class 3 ·BIOTRIN PARVOVIRUS B19 IGG

    Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

    FDA classification
    FDA Not Classified ·Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur HBc Total ReadyPack Reagents, ADVIA Centaur HBc Total Quality Control Materials, Atellica IM Anti-Hepatiti

    Igm, Fitc, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igm, Fitc, Antigen, Antiserum, Control

    Igm, Ferritin, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igm, Ferritin, Antigen, Antiserum, Control

    Antibody Igm,If, Cytomegalovirus Virus

    FDA classification
    FDA Class 2 ·Antibody Igm,If, Cytomegalovirus Virus

    Igm, Rhodamine, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igm, Rhodamine, Antigen, Antiserum, Control

    Igm, Peroxidase, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igm, Peroxidase, Antigen, Antiserum, Control

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur anti-HBs2 (aHBs2), ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material, Atellica IM Anti-Hepatitis B

    Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

    FDA classification
    FDA Class 2 ·Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

    Elisa, Antibody, West Nile Virus

    FDA classification
    FDA Class 2 ·Elisa, Antibody, West Nile Virus

    Immunoassay Multi Control

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    Antibody Igm, If, Epstein-Barr Virus

    FDA classification
    FDA Class 1 ·Antibody Igm, If, Epstein-Barr Virus

    EUCEREP B.V.

    Authorized representative
    🇳🇱 Netherlands·19 Manufacturers·66 Devices

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS