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510(k) Data Aggregation

    K Number
    K250205
    Device Name
    Babio® Virus Transport Kit (Non-inactivating)
    Manufacturer
    Jinan Babio Biotechnology Co., Ltd.
    Date Cleared
    2025-09-22

    (241 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Babio Virus Transport Kit (Non-inactivating) is intended for the collection and transportation of clinical specimens for preservation of viral agents including Influenza A, Herpes Simplex Virus-1, and Adenovirus from the collection site to the testing laboratory. The Babio Virus Transport Kit contains a culture-based medium that is intended to be used for standard laboratory procedures of virus culture and diagnostic assays which utilize stable recoverable infectious viral particles.

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