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510(k) Data Aggregation

    K Number
    K240797
    Device Name
    PPH Saliva Collection Kit
    Manufacturer
    Permantis Public Health
    Date Cleared
    2024-10-11

    (203 days)

    Product Code
    QBD, OBD
    Regulation Number
    866.2950
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    Applicant Name (Manufacturer) :

    Permantis Public Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PPH Saliva Collection Kit is designed for use in the non-invasivation, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.
    Device Description
    The PPH Saliva Collection Device contains a plastic bulb pipette, paper cup, plastic tube with PPH Saliva collection buffer (0.3 ml). This collection device designed for the collection of human saliva samples. It is designed for use in the non-invasive collection, inactivation of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature.
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