Recognized standard
M27 4th Edition
FDA recognition 7-278 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-278 |
|---|---|
| Designation | M27 4th Edition |
| Title | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard covers antifungal agent selection and preparation, test procedure implementation and interpretation, and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections. |
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: