BEUDAMED
    14 results · 40ms · Sources: EU EUDAMED, US FDA
    Filters FDA Classification ×

    Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

    FDA classification
    FDA Class 1 ·Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

    Dilator, Cervical, Fixed Size

    FDA classification
    FDA Class 1 ·Dilator, Cervical, Fixed Size

    Antigen, Antiserum, Control, Antithrombin Iii

    FDA classification
    FDA Class 2 ·Antigen, Antiserum, Control, Antithrombin Iii

    Urease And Glutamic Dehydrogenase, Urea Nitrogen

    FDA classification
    FDA Class 2 ·Urease And Glutamic Dehydrogenase, Urea Nitrogen

    Ldt, Approved By Nys Clep

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

    Ldl & Vldl Precipitation, Hdl

    FDA classification
    FDA Class 1 ·Ldl & Vldl Precipitation, Hdl

    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

    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

    FDA classification
    FDA Class 1 ·Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    FDA classification
    FDA Class 3 ·Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    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