BEUDAMED
    7,797 results · 41ms · Sources: EU EUDAMED, US FDA

    Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·1 device

    Dengue IgG & IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Hunan Kangxin Biotechnology Co., Ltd.·1 device

    COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·JOYSBIO(Tianjin) Biotechnology Co., Ltd.·1 device

    Access SARS-CoV-2 IgG (1st IS) (Reagent pack)

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

    Igg (Fd Fragment Specific), Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Igg (Fd Fragment Specific), Antigen, Antiserum, Control

    Igg (Fab Fragment Specific), Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Igg (Fab Fragment Specific), Antigen, Antiserum, Control

    Igg (Fc Fragment Specific), Antigen, Antiserum, Control

    FDA classification
    FDA Class 1 ·Igg (Fc Fragment Specific), Antigen, Antiserum, Control

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    FDA classification
    FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    Igg (Gamma Chain Specific), Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Igg (Gamma Chain Specific), Antigen, Antiserum, Control

    Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

    FDA classification
    FDA Class 2 ·Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

    GG Brands Netherlands BV

    Authorized representative
    🇳🇱 Netherlands·1 Manufacturer·1 Device

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

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

    Development Solution

    FDA registration
    PHADIA AB·1 product·🇸🇪 Sweden

    Development Solution

    FDA registration
    PHADIA AB·1 product·🇸🇪 Sweden

    Development Solution

    FDA registration
    PHADIA US INC.·1 product·🇺🇸 United States

    Antibodies, Anti-Actin, Anti-Smooth Muscle

    FDA classification
    FDA Class 2 ·Antibodies, Anti-Actin, Anti-Smooth Muscle

    Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Ningbo BESTest Bio-technology Co.,Ltd.·1 device

    Dengue IgG/IgM+NS1 Antigen Rapid Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Ningbo BESTest Bio-technology Co.,Ltd.·1 device

    RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device

    TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·Qingdao Hightop Biotech Co., Ltd.·1 device