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BD™ Plasma Count Kit
(CE_IVD)Plasma Count 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 Plasma Count kit is intended for in vitro diagnostic use to identify and enumerate residual leucocytes (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) in fresh human plasma, using flow cytometry.
Preparation And Storage
• Store the BD Plasma Count kit at 2° to 8° C. Do not use after the expiration date shown on the label.
• Avoid unnecessary exposure of the reagents to light.
• The BD Trucount tubes are packaged in two foil pouches. Each pouch contains 25 tubes and desiccant. Store BD Trucount tubes in their original foil pouch at 2° 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. Use tubes within 1 hour after removal from the foil pouch. Once the pouch has been opened, the tubes are stable for 1 month. Do not use beyond the expiration date indicated on the packaging.
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Jennings LK, Ashmun RA, Wang WC, Dockter ME. Analysis of human platelet glycoproteins IIb-IIIa and Glanzmann's thrombasthenia in whole blood by flow cytometry.. Blood. 1986; 68(1):173-9. (Biology). View Reference
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Jilma-Stohlawetz P, Marsik C, Horvath M, Siegmeth H, Hocker P, Jilma B. A new ow cytometric method for simultaneous measurement of residual platelets and RBCs in plasma: validation and application for QC. Transfusion. 2001; 41(1):87–92. (Biology).
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Vowells S, Cadden M, Wagner C, Nuñez R. Quality of therapeutic plasmarequirements for marketing authorization. Detection and Enumeration of Residual White Blood Cells in Leucoreduced Red Blood Cell and Platelet Products Using the LeucoCOUNT Kit. 1998. (Biology).
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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.