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Whole Blood Control for Lymphocyte Subset Enumeration

Whole Blood Control for Lymphocyte Subset Enumeration

(CE_IVD)
Product Details
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BD™ Multi-Check
Flow cytometry
CE_IVD


Description

The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.

Preparation And Storage

• 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 Assay Values sheet.

• Opened vials are stable for 9 thermal cycles (uses) when handled properly. A thermal cycle constitutes performing all steps under Instructions for Use once.

• Avoid unnecessary cycles of warming and cooling.

• Protect from freezing, from temperatures above 30°C, and from prolonged time (>30 minutes) at room temperature (18° to 26°C).

• Follow exactly the steps under Instructions for Use.

340912 Rev. 1
Citations & References
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Development References (4)

  1. Centers for Disease Control. Revised guidelines for performing CD4+ T-cell determinations in persons infected with human immunodeficiency virus (HIV). MMWR. 1997; 46:1-29. (Biology).
  2. Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping of Lymphocytes: Approved Guideline. NCCLS document H42-A. 1998. (Biology).
  3. 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).
  4. Villanova, PA: National Committee for Clinical Laboratory Standards; Clinical Applications of Flow Cytometry: Immunophenotyping of Leukemic Cells; Approved Guideline. H43-A. 1998. (Biology).
340912 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