Recognized standard
M51-A (Replaces M51-P)
FDA recognition 7-243 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-243 |
|---|---|
| Designation | M51-A (Replaces M51-P) |
| Title | Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This document describes the guidelines for antifungal susceptibility testing by the disk diffusion method of nondermatophyte filamentous fungi (moulds) that cause invasive disease. |
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: