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510(k) Data Aggregation
K Number
K162723Device Name
TransFix/EDTA Vacuum Blood Collection Tubes
Manufacturer
Caltag Medsystems Ltd.
Date Cleared
2017-06-22
(266 days)
Product Code
GIM
Regulation Number
862.1675Why 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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