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510(k) Data Aggregation

    K Number
    K220908
    Device Name
    Ensol EnTM Specimen Collection and Transport System
    Manufacturer
    Ensol Biosciences Inc.
    Date Cleared
    2024-08-29

    (884 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ensol Biosciences Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ensol EnTM Collection and Transport System is intended for the collection of clinical samples containing upper respiratory viruses including Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus (RSV) from the collection site to the testing laboratory to be used with standard diagnostic identification techniques that utilize stable recoverable infectious viral particles.
    Device Description
    The EnTM Collection and Transport System medium consists of a polypropylene conical tube filled with 2 ml of the transport medium (pale brown to red color medium solution), affixed with a polyethylene screw cap. The bottom part of the tube has a self-standing shape. Tubes are provided in a paper rack. The media tubes can be provided with one or two kinds of sterile specimen collection swabs, one for oropharyngeal (OP) oral use and the other nasopharyngeal (NP) for nasal use. The swab shaft is polystyrene with a breaking point, and the swab tip is flocked nylon fibers. The media is provided in two different configurations with and without the sterile peel pouch containing swabs.
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