Recognized standard
M07 11th Edition
FDA recognition 7-279 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-279 |
|---|---|
| Designation | M07 11th Edition |
| Title | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard describes standard broth (macrodiluation and microdiluation) and agar diluation emthods for determining in vitro susceptibility to antimicrobial agents for bacteria that grow aerobically. |
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: