광고심의필 : 심의번호 2019-I10-43-3455
이 제품은 '의료기기'이며, '사용상의 주의사항'과 '사용방법'을 잘 읽고 사용하십시오.
설명
The BD Leucocount™ RBC control is used to monitor methods for enumeration of residual leucocytes in leucoreduced RBC products, including the dilution and staining process, method setup, and WBC enumeration.
준비 및 보관
• Store vials upright, tightly capped, at 2° to 8°C when not in use.
• Unopened vials are stable until the expiration date indicated on each vial and on the Assay Values sheet when stored continuously at 2° to 8°C.
• Opened vials are stable for 30 days or 21 thermal cycles (uses), whichever comes first, when handled properly. A thermal cycle constitutes performing all steps once under Instructions for Use. In general, stability is limited by the number of times the vial is removed from the refrigerator, warmed, and mixed (defined as a use ); by the time from first use; and by the decrease in volume with each use.
• Protect from freezing, from temperatures above 30°C, and from prolonged time at room temperature (18° to 30°C).
• Follow exactly the steps under Instructions for Use.
개발 참고 자료 (6)
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Center for Biologics Evaluation and Research. Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products. 1996. (Biology).
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Dumont LJ, Dzik WH, Rebulla P, Brandwein H Practical guidelines for process validation and process control of white cell-reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfusion. 1996; 11-20. (Biology).
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Rebulla P, Porretti L, Bertolini F, et al. White cellreduced red cells prepared by filtration: a critical evaluation of current filters and methods for counting residual white blood cells. Transfusion. 1993; 33:128-133. (Biology).
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Vachula M, Simpson SJ, Martinson JA, et al. A flow cytometric method for counting very low levels of white cells in blood and blood components. Transfusion. 1993; 33:262-267. (Biology).
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Venglen-Tyler V, ed. Leukoreduction of RBC and platelet units. American Association of Blood Banks. 1996; 722-725. (Biology).
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Wenz B, Gurtlinger KF, O’Toole AM, Dugan EP. Preparation of granulocyte-poor red blood cells by microaggregate filtration: a simplified method to minimize febrile transfusion reactions. Vox Sang. 1980; 39:282–287. (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.
