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510(k) Data Aggregation

    K Number
    K211675
    Device Name
    Dasky Disposable Sampling Tube (Model name: VSM02)
    Date Cleared
    2022-08-08

    (433 days)

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

    Ningbo Dasky Life Science Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
    Device Description
    The Dasky Disposable Sampling Tube (Model name: VSM02) consists of a plastic transport tube with medium which is supplied alone or in a kit with a nasopharyngeal (NP) swab, and an optional biosafety bag. The plastic transport tube contains 3 mL of the stabilization media. The media are intended to inactivate SARS-CoV-2 virus, lyse the cells, disruptlyse the lipid membranes and denature proteins for storage of the specimen between 39 °F and 73 °F (4°C - 23°C). The media is sold in the following configurations. - . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media. - . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media and a NP nylon flocked swab for sample collection.
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