Recognized standard
M27M44S, 3rd Edition
FDA recognition 7-314 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-314 |
|---|---|
| Designation | M27M44S, 3rd Edition |
| Title | Performance Standards for Antifungal Susceptibility Testing of Yeasts |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | Clinical and Laboratory Standards Institute document M27M44S - Performance Standards for Antifungal Susceptibility Testing of Yeasts includes minimal inhibitory concentration, zone diameter, and quality control tables developed following the guidance in CLSI documents M27 and M44 The data in the… |
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: