Recognized standard
M44-S3 (2018)
FDA recognition 7-287 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-287 |
|---|---|
| Designation | M44-S3 (2018) |
| Title | Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard provides approved zone interpretive criteria (breakpoints) for Candida species for caspofungin, fluconazole, and voriconazole after 20 to 24 hours incubation, as well as quality control parameters for caspofungin, fluconazole, posaconazole, and voriconazole. There are currently more… |
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: