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Hematology
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H02A4
Reference and Selected Procedure for the Erythrocyte Sedimentation Rate (ESR) Test; Approved Standard - Fourth Edition
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American National Standard.* This document provides a description of the principle, materials, and procedure for reference and standardized ESR methods as well as a procedure to evaluate routine methods and an outline of quality control programs for the ESR test.Erythrocyte sedimentation, erythrocyte sedimentation rate (ESR) test, quality control, reference
procedure, standardized procedure, Westergren pipet
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H20A2
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
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This document is a reference method for the evaluation of automated differential counters, based on the visual differential count.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement. Basophil, blood film differential leukocyte count, differential counting, eosinophil, leukocyte, lymphocyte, lymphocyte variant form, monocyte, neutrophil band form, neutrophil segmented
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H26A2
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard-Second Edition
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This document provides guidance for the validation, verification, calibration, quality assurance (QA), and quality control (QC) of automated multichannel hematology analyzers for manufacturers, end-user clinical laboratories, accrediting organizations, and regulatory bodies. In addition, end-user clinical laboratories will find guidance for establishment of clinically reportable intervals and for QA for preexamination and examination aspects of their systems.
Analytical measuring interval, automated hematology, carryover, clinically reportable interval, comparability, correlation, imprecision, limit of blank, lower limit of detection, lower limit of quantitation, quality control, reference intervals, repeatability, validation study design, verification study design
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H42A2
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition
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This document provides guidance for the immunophenotypic analysis of lymphocyte subsets and CD34+ (hematopoietic) stem cells by immunofluorescence-based flow cytometry; sample and instrument quality control; and precautions for acquisition of data from lymphocytes and CD34+ stem cells.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
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H43A2
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
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This document provides performance guidelines for the immunophenotypic analysis of neoplastic hematolymphoid cells using immunofluorescence-based flow cytometry; for sample and instrument quality control; and precautions for acquisition of data from neoplastic hematolymphoid cells.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
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