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510(k) Data Aggregation

    K Number
    K231027
    Device Name
    KaiBiLi Extended ViralTrans
    Date Cleared
    2023-12-21

    (254 days)

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

    **Hangzhou Genesis Biodetection **& Biocontrol Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KaiBiLi Extended ViralTrans is intended for the collection of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.
    Device Description
    The KaiBiLi Extended ViralTrans is room temperature stable and can sustain the viability of virus, chlamydiae, mycoplasma and ureaplasma when transported at 2-8°C or 20-25°C. The product can maintain proper pH environment and inhibit the growth of indigenous microbiota. KaiBiLi Extended ViralTrans consists of modified Hank's balanced salt solution supplemented with bovine serum albumin, cysteine, glutamic acid, sucrose and HEPES. The HEPES buffer protects against pH changes. Phenol red is used as a pH indicator. Sucrose aids in the preservation of organism viability. To minimize the contamination of commensal organisms, Vancomycin, Econazole Nitrate, and Polymyxin B are incorporated into the medium formula. KaiBiLi Extended ViralTrans is supplied as one plastic flat-bottom vial along with a screw cap for safely containing and transporting biological specimens. The vial is filled with either 1 mL or 3 mL of transport medium and glass beads, or in a kit format together with collection swabs.
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