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BD FACSPresto™ Cartridge Kit
(CE_IVD)Cartridge Kit
Regulatory Status Legend
Any use of products other than the permitted use without the express written authorization of Becton, Dickinson and Company is strictly prohibited.
Description
The BD FACSPresto Cartridge kit is designed for venous and capillary finger-stick whole blood application. It comes with 100 cartridges (657681) and Finger-stick sample collection kit for 100 samples which has 100 BD CAL Lancets, 100 Alcohol Swabs packets, 100 Cotton Gauze packets and 100 Band Aids. The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
Preparation And Storage
Store the cartridge: • In its original foil pouch. Do not use the cartridge if the pouch has been opened for more than 30 minutes. • At 4°C–31°C (39°F–88°F). • In 10%–95% non-condensing humidity. • Until the expiration date. Do not use the cartridge after the expiration date on the package. Incubate the cartridge at 10°C–40°C (50°F–104°F).
Development References (29)
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Please refer to Support Documents for Quality Certificates
Global - Refer to manufacturer's instructions for use and related User Manuals and Technical data sheets before using this products as described
Comparisons, where applicable, are made against older BD Technology, manual methods or are general performance claims. Comparisons are not made against non-BD technologies, unless otherwise noted.
For In Vitro Diagnostic Use.
23-22942-00
Documents are subject to revision without notice. Please verify you have the correct revision of the document, and always refer back to BD's eIFU website for the latest and most up to date information.