BEUDAMED
    431 results · 42ms · Sources: EU EUDAMED, US FDA
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    Myeloperoxidase, Immunoassay, System, Test

    FDA classification
    FDA Class 2 ·Myeloperoxidase, Immunoassay, System, Test

    Inherited Nucleotide Repeat Disorder Dna Test

    FDA classification
    FDA Class 2 ·Inherited Nucleotide Repeat Disorder Dna Test

    High Throughput Dna Sequence Analyzer

    FDA classification
    FDA Class 2 ·High Throughput Dna Sequence Analyzer

    Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

    FDA classification
    Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

    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

    Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

    FDA classification
    FDA Class 2 ·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay

    Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

    FDA classification
    FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

    Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

    FDA classification
    FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

    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

    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

    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