BEUDAMED
    10 results · 37ms · Sources: EU EUDAMED, US FDA
    Filters FDA Classification ×

    Assay, Erythropoietin

    FDA classification
    FDA Class 2 ·Assay, Erythropoietin

    Radioimmunoassay, Cyclic Gmp

    FDA classification
    FDA Class 2 ·Radioimmunoassay, Cyclic Gmp

    Controller, Temperature, Radiographic

    FDA classification
    FDA Class 2 ·Controller, Temperature, Radiographic

    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

    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