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    K Number
    K202531
    Device Name
    Azer Scientific Universal Transport Medium
    Manufacturer
    Azer Scientific, Inc.
    Date Cleared
    2024-04-11

    (1318 days)

    Product Code
    JSM
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Azer Scientific, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
    Device Description
    The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.
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