Recognized standard
M45 3rd Edition
FDA recognition 7-262 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-262 |
|---|---|
| Designation | M45 3rd Edition |
| Title | Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | CLSI documents M02, M07, and M100 describe standardized methods and interpretive criteria for antimicrobial susceptibility testing of common aerobic bacteria, including some fastidious organisms. However, a number of less frequently encountered or fastidious bacteria are not addressed in those CLSI… |
At a glance
- 10–99 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: