Recognized standard
H42-A2 (Replaces H42-A)
FDA recognition 7-145 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-145 |
|---|---|
| Designation | H42-A2 (Replaces H42-A) |
| Title | Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 18, 2009 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard was developed to address issues of procedures and quality assurance for clinical applications of flow cytometry. It is designed to aid clinical laboratorians in the development of quality assurance procedures and to establish the foundation for different laboratories using different… |
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: