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510(k) Data Aggregation

    K Number
    K212113
    Device Name
    MagXtract Collection Tube
    Manufacturer
    MagBio Genomics, Inc.
    Date Cleared
    2022-07-28

    (386 days)

    Product Code
    QBD
    Regulation Number
    866.2950
    Why did this record match?
    Applicant Name (Manufacturer) :

    MagBio Genomics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MagXtract Collection Tube is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA. These devices can be used for collection transport and storage of specimens at refrigerated (2-8℃) or ambient temperatures (20-25℃). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.
    Device Description
    The MagXtract collection tube is intended for the collection, transportation, direct lysis, and stabilization of RNA from unprocessed nasopharyngeal swab samples suspected of containing SARS-COV-2. The MagXtract collection tube stores and transports specimens in a closed tube. Proper specimen collection and transport are essential in molecular testing and obtaining accurate test results. MagXtract collection tube allows for the stabilization and transportation of nasopharyngeal swab samples at ambient temperature from the collection site to the processing laboratory. The MagXtract collection tube consists of a sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer (MagBio CTL Medium). MagBio CTL Medium is intended to disrupt/lyse cells and stabilize SARS-COV-2. The preserved and stabilized RNA maintains its integrity for downstream molecular based detection/analysis. MagXtract collection tube may be used in conjunction with a swab or as a tube alone.
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