Recognized standard
M38M51S 3rd Edition
FDA recognition 7-330 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-330 |
|---|---|
| Designation | M38M51S 3rd Edition |
| Title | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Scope (excerpt) | This document provides minimal inhibitory concentration (MIC) breakpoints and quality control (QC) tables for use with CLSI antifungal susceptibility testing standards M38 and M51. It ensures laboratories have the most up-to-date reference data for accurate and standardized susceptibility testing of… |
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: