BEUDAMED
    12 results · 35ms · Sources: EU EUDAMED, US FDA
    Filters FDA Classification ×

    Respiratory Syncytial Virus, Antigen, Antibody, Ifa

    FDA classification
    FDA Class 1 ·Respiratory Syncytial Virus, Antigen, Antibody, Ifa

    Curette, Endodontic

    FDA classification
    FDA Class 1 ·Curette, Endodontic

    Free Radical Assay, Opiates

    FDA classification
    FDA Class 2 ·Free Radical Assay, Opiates

    Ldt, Approved By Nys Clep

    FDA classification
    FDA Not Classified ·Ldt, Approved By Nys Clep

    Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

    Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    Ldt, Unmet Need Within An Integrated Healthcare System

    FDA classification
    FDA Not Classified ·Ldt, Unmet Need Within An Integrated Healthcare System

    Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

    FDA classification
    FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

    Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

    Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    FDA classification
    FDA Not Classified ·Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

    Pierced Ear/Entry Cleaning Tray

    FDA classification
    FDA Class 1 ·Pierced Ear/Entry Cleaning Tray