Recognized standard
H62 1st Edition
FDA recognition 7-320 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-320 |
|---|---|
| Designation | H62 1st Edition |
| Title | Validation of Assays Performed by Flow Cytometry |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | This guideline focuses on the unique requirements for the analytical validation of cell-based assays performed by flow cytometry, which are not covered in other CLSI documents. Although flow cytometry can be used for a wide variety of applications other than cellular analysis, this guideline focuses… |
At a glance
- None 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: