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510(k) Data Aggregation

    K Number
    K221802
    Device Name
    iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
    Manufacturer
    Mawi DNA Technologies
    Date Cleared
    2023-04-03

    (286 days)

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

    Mawi DNA Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iSWAB-Respiratory Tract Sample Collection Media-Extraction device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.
    Device Description
    The iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB™ -RC-EL) collection device consists of a collection tube that is pre-filled with 800 µL of the iSWAB™-RC-EL nontoxic, stabilizing buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the stabilizing buffer, creating a minimal footprint and allowing for swab-free transport of specimens. The iSWAB™-RC-EL collection device eliminates the costly and timeconsuming RNA isolation step from diagnostic workflows.
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