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510(k) Data Aggregation

    K Number
    K222771
    Device Name
    Sample Preservative Fluid
    Manufacturer
    Hangzhou Bioer Technology Co., LTD
    Date Cleared
    2024-06-26

    (651 days)

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

    Hangzhou Bioer Technology Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sample Preservative Fluid is intended for the stabilization, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
    Device Description
    Sample Preservative Fluid is a medium for stabilization of Influenza A RNA during sample transport/storage. The fluid is composed of quanidine thiocyanate, Triton X-100, and nuclease-free water. Sample Preservative Fluid is provided in a labeled screw-cap tube. Sample Preservative Fluid configuration: - BSC82X1-A1: a screw-cap tube filled with 2 mL of Sample Preservative Fluid liquid ● and a prepackaged nasopharyngeal swab for sample collection - Nasopharyngeal swab: regular size, sterile disposable sample swab (80mm . breakpoint)
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