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510(k) Data Aggregation

    K Number
    K162723
    Device Name
    TransFix/EDTA Vacuum Blood Collection Tubes
    Manufacturer
    Caltag Medsystems Ltd.
    Date Cleared
    2017-06-22

    (266 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Caltag Medsystems Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of the HIV panel can be accomplished over a 14-day period following collection. TVTs are in-vitro diagnostic medical devices.
    Device Description
    TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells (WBC, leukocytes) by flow cytometry up to 14-days following collection; the TVTs preserve the qualitative and quantitative leukocyte subset characteristics. Flow cytometry is used to identify subsets of leukocytes that can be distinguished on the basis of cell surface antigens using fluorescent antibodies. The TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) consist of purple-capped polyethylene terephthalate blood collection tubes containing the paraformaldehyde based preservative, TransFix, and K2EDTA at the correct volume to simultaneously stabilize and anticoagulate human whole blood at the time of collection. TVTs hold 3mL (final draw volume) with a tube dimension of 13 x 75mm. TVTs are sterilized by gamma radiation. Further, the vacuum contained within the TVT ensures that the TransFix/EDTA reagent is administered at the correct ratio of 1 part TransFix/EDTA to 5 parts whole blood.
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