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BD™ Stem Cell Enumeration Kit
(CE_IVD)
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® Stem Cell Enumeration (SCE) Kit provides simultaneous enumeration of viable dual-positive CD45+/CD34+ hematopoietic stem cell populations in CD34+ absolute counts (cells/µL) as well as the percentage of the total viable leucocyte count that is CD34+ (%CD34). The following specimens can be analyzed with this kit: normal and mobilized peripheral blood, fresh and thawed leukapheresis products, fresh and thawed bone marrow, and fresh and thawed cord blood. The kit is intended for in vitro diagnostic (IVD) use on a BD FACSLyric™ Flow Cytometer using BD FACSuite™ Clinical Application or a BD FACSCanto™ II Flow Cytometer using BD FACSCanto™ Clinical Software or a BD FACSCalibur™ Flow Cytometer using BD CellQuest™ or BD CellQuest™ Pro Software.
Contents: BD® Stem Cell Reagent (CD45 FITC/CD34 PE), 7-aminoactinomycin-D (7-AAD) reagent, 10X ammonium chloride lysing solution, 50 BD Trucount™ Tubes.
Preparation And Storage
• Store the BD Stem Cell (CD45/CD34) reagent at 2°C to 8°C. Do not use after the expiration date shown on the label. Do not freeze the reagent or expose it to direct light during storage or incubation with cells. Keep the reagent vial dry.
• Store BD Trucount tubes in their original foil pouch at 2°C to 25°C. To avoid potential condensation, open the pouch only after it has reached room temperature and carefully reseal the pouch immediately after removing a tube. Examine the desiccant each time you open the pouch. If the desiccant has turned from blue to lavender, discard the remaining tubes. An unopened pouch is stable until the expiration date shown on the packaging. Do not open and use tubes after this expiration date. Use tubes within 1 hour after removal from the foil pouch. Use remaining tubes within 1 month after opening the pouch.
• Store 7-AAD at 2°C to 8°C. Protect from light.
• Store 10X ammonium chloride at 2°C to 8°C.
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.