Recognized standard
H43-A2
FDA recognition 7-150 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-150 |
|---|---|
| Designation | H43-A2 |
| Title | Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | 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. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: