Recognized standard
MM24 1st Edition
FDA recognition 7-321 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-321 |
|---|---|
| Designation | MM24 1st Edition |
| Title | Molecular Methods for Genotyping and Strain Typing of Infectious Organisms |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 29, 2024 |
| Scope (excerpt) | This guideline examines the biology behind molecular strain typing and genotyping, as well as characterization and validation of these systems. It also provides recommendations regarding criteria to be considered for design, validation, and determination of clinical utility of such testing. |
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: