Recognized standard
M100 34th Edition
FDA recognition 7-327 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-327 |
|---|---|
| Designation | M100 34th Edition |
| Title | Performance Standards for Antimicrobial Susceptibility Testing |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | The data in the tables are valid only if the methodologies in CLSI documents M02, M07, and M11 are followed. These standards contain information about disk diffusion (M02) and dilution (M07 and M11) test procedures for aerobic and anaerobic bacteria. Clinicians depend heavily on information from 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: