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Stem Cell Control CD34+ Whole Blood Process Control

Stem Cell Control CD34+ Whole Blood Process Control

(CE_IVD)
Product Details
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BD™
Human
Flow cytometry
CE_IVD


Description

The BD™ Stem Cell control is intended as a complete, two-level, process control for immunophenotyping and enumeration of leucocytes by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.

Contents: 1 x 2.0 ml CD34+ Low approx. 10 cells/µl, and 1 x 2.0 ml CD34+ High approx. 35 cells/µl.


The BD™ Stem Cell control is intended as a complete, two-level, process control for immunophenotyping and enumeration of leucocytes by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.

Contents: 1 x 2.0 ml CD34+ Low approx. 10 cells/µl, and 1 x 2.0 ml CD34+ High approx. 35 cells/µl.

Preparation And Storage

• Store vials upright, tightly capped, at 2°C to 8°C when not in use.

• Unopened vials are stable until the expiration date indicated on each vial and assay sheet.

• Opened vials are stable for 12 thermal cycles (uses) when handled properly. A thermal cycle constitutes performing all steps under Section 5, Instructions for Use, once.

• Avoid unnecessary cycles of warming and cooling. Protect this product from freezing, from temperatures above 30°C, and from prolonged time at room temperature (18°C to 26°C). Follow exactly the steps in Section 5 Instructions For Use.

340991 Rev. 1
Components
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Description Quantity/Size Part Number
CD34+ Low (approx. 10 cells/µl) 2 mL (1 ea) 340991-02
CD34+ High (approx. 35 cells/µl) 2 mL (1 ea) 340991-01
340991 Rev. 1
Citations & References
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Development References (8)

  1. Centers for Disease Control. Revised Guidelines for the Performance of CD4+ T-Cell Determinations in Persons with HIV Infection. MMWR. 1994; 43:1-21. (Biology).
  2. Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping of Lymphocytes: Approved Guideline. NCCLS document H42-A. 1998. (Biology).
  3. Gratama JW, Orfao A, Barnett D, et al. Flow cytometric enumeration of CD34+ hematopoietic stem and progenitor cells. Cytometry. 1998; 34:128–142. (Biology).
  4. Marti G, Johnsen H, Sutherland R, Serke S. Letter to the Editor: A convergence of methods for a worldwide standard for CD34+ cell enumeration. J Hematotherapy. 1998; 7:105-109. (Biology).
  5. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline. NCCLS document C-24A2. 1999. (Biology).
  6. Stelzer GT, Marti G, Hurley A, McCoy PJ, Lovett EJ, Schwartz A. US-Canadian consensus recommendations on the immunophenotypic analysis of hematologic neoplasia by flow cytometry: standardization and validation of laboratory procedures. Cytometry. 1997; 30:214-230. (Biology).
  7. Sutherland DR, Anderson L, Keeney M, Nayar R, Chin-Yee I. The ISHAGE guidelines for CD34+ cell determination by flow cytometry. J Hematotherapy. 1996; 5:213-226. (Biology).
  8. Villanova, PA: National Committee for Clinical Laboratory Standards; Clinical Applications of Flow Cytometry: Immunophenotyping of Leukemic Cells; Approved Guideline. H43-A. 1998. (Biology).
View All (8) View Less
340991 Rev. 1

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