BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    miDiagnostics HSV-1&2 CSF Test

    K Number: K250050 · Decision Sep 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    263

    Basic Information

    Device Name
    miDiagnostics HSV-1&2 CSF Test
    K Number
    K250050
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3307
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Midiagnostics NV
    Date Received
    January 10, 2025
    Decision Date
    September 30, 2025
    Product Code
    PGH
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

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