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510(k) Data Aggregation

    K Number
    K212856
    Device Name
    iClean Viral Transport System (VTM-RT kit)
    Manufacturer
    Huachenyang (Shenzhen) Technology Co. Ltd.
    Date Cleared
    2022-08-18

    (344 days)

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

    Huachenyang (Shenzhen) Technology Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis 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 or bacteria.
    Device Description
    iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. iClean Viral Transport System (VTM-RT) includes a plastic screw-cap tube with conical bottom containing 3mL transport medium. iClean Viral Transport System (VTM-RT) tubes can be supplied alone, or in a kit format with a flocked swab in a sterile peel pouch (or 100 kits packed together in a color box). iClean Viral Transport System (VTM-RT) medium is stable at room temperature and consists of: Hanks balanced salt solution (HBSS), Bovine Serum Albumin (BSA), Gentamicin sulfate, Amphotericin B, Colistin, L-glutamic acid, HEPES buffer and Phenol red.
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