BEUDAMED
    10,000 results · 325ms · Sources: EU EUDAMED, US FDA

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM

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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX Anti-HBe; LIAISON XL MUREX Control Anti-HBe

    Trinity Biotech

    FDA UDI
    MARDX DIAGNOSTICS, INC.·05391516747943·FITC Mounting Medium (pH 7.5), 3.0 mL

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM, AUSAB

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT AUSAB

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

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO

    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT AXSYM HAVAB 2.0

    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

    FDA 510(k)
    FDA Class 2 ·Immunology

    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    8801074 NDI Sterile Passive Markers - 4 spheres in tray 12 trays per box OEM 509

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Northern Digital Inc.·1 device

    8801071 NDI Sterile Passive Markers - 1 sphere in tray 12 trays per box OEM 509

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Northern Digital Inc.·1 device

    8801075 NDI Sterile Passive Markers - 5 spheres in tray 12 trays per box OEM 509

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Northern Digital Inc.·1 device

    8801085 NDI Sterile Passive Markers - 5 spheres in tray 1 tray per box OEM 509

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Northern Digital Inc.·1 device