Recognized standard
M39 5th Edition
FDA recognition 7-312 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-312 |
|---|---|
| Designation | M39 5th Edition |
| Title | Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 30, 2022 |
| Device classes | Class 2 |
| Scope (excerpt) | This guideline provides individuals involved with assessment of cumulative antimicrobial susceptibility test data with recommendations for the storage, analysis, and presentation of the data. The antimicrobial susceptibility test data from individual patient's isolates available for analysis are… |
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: