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BD OneFlow™ Setup Beads
(CE_IVD)Setup Beads
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
BD OneFlow™ Setup beads are intended to set voltages appropriate for the BD multicolor tube assay when used with a suitably equipped BD™ flow cytometer and software designated for in vitro diagnostic use.
Preparation And Storage
• Store the vial at 2°C–8°C. The vial should not be frozen. Protect from exposure to light. The beads are stable until the expiration date shown on the vial label when stored as directed. Do not use after the expiration date. Do not mix the contents of one kit with another. Target values can vary between lots and this could result in inaccurate detector settings. • After dilution, the beads are stable for – 1 hour at 18°C–25°C – 8 hours at 2°C–8°C WARNING Protect the diluted bead suspension from light. Some of the dyes used to manufacture the beads are very light sensitive. Fluorescence levels can change if the beads are exposed to direct light for longer than 20 minutes.
Development References (2)
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Centers for Disease Control. Perspectives in disease prevention and health promotion update: universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. MMWR. 1988; 37:377-388. (Biology).
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Clinical and Laboratory Standards Institute. 2005. (Biology).
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.