Recognized standard
M11 9th Edition
FDA recognition 7-286 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-286 |
|---|---|
| Designation | M11 9th Edition |
| Title | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | Susceptibility testing is indicated for any organism that contributes to an infectious process warranting antimicrobial chemotherapy if its susceptibility cannot reliably be predicted from existing antibiograms. Antimicrobial resistance patterns for many anaerobic bacteria have changed significantly… |
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: