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510(k) Data Aggregation

    K Number
    K233449
    Device Name
    Avantik VTM
    Manufacturer
    Hanchang Medic Co., Ltd. (Han Chang Medic)
    Date Cleared
    2024-07-15

    (269 days)

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

    Hanchang Medic Co., Ltd. (Han Chang Medic)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.
    Device Description
    The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories. The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours. The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.
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