Recognized standard
H56-A (Replaces H56-P)
FDA recognition 7-163 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-163 |
|---|---|
| Designation | H56-A (Replaces H56-P) |
| Title | Body Fluid Analysis for Cellular Composition; Approved Guideline. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 2 |
| Scope (excerpt) | This guideline provides users with recommendations for collection and transport of body fluids, numeration and identification of cellular components, and guidance for qualitative and quantitative assessment of body fluid. |
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: