Recognized standard
M02 14th Edition
FDA recognition 7-325 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-325 |
|---|---|
| Designation | M02 14th Edition |
| Title | Performance Standards for Antimicrobial Disk Susceptibility Tests |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard describes the reference disk diffusion method used to determine the in vitro antimicrobial susceptibility of bacteria that grow aerobically and includes: - Agar plate preparation - Testing conditions, including inoculum preparation and standardization, incubation time, and incubation… |
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: