BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    Burn Resuscitation Decision Support Software

    FDA classification
    FDA Class 2 ·Burn Resuscitation Decision Support Software

    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

    FDA classification
    FDA Class 1 ·Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

    Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

    FDA classification
    FDA Class 2 ·Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control

    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

    Sealant, Pit And Fissure, And Conditioner

    FDA classification
    FDA Class 2 ·Sealant, Pit And Fissure, And Conditioner

    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

    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

    Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

    FDA classification
    FDA Class 2 ·Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

    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

    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

    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

    FDA classification
    FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission