| CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 7-279 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Ribhi Shawar FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6698 ribhi.shawar@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.1645 | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | Class 2 | LON |
| §866.1640 | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | Class 2 | LRG |
| §866.1640 | Manual Antimicrobial Susceptibility Test Systems | Class 2 | JWY |
| §866.1640 | Panels, Test, Susceptibility, Antimicrobial | Class 2 | LTT |
| §866.1640 | Susceptibility Test Cards, Antimicrobial | Class 2 | LTW |
| Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued March 5, 2007. |