| CLSI M43-A Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. |
| Recognition Date | 2013-01-15 |
| Recognition List | 030 |
| Recognition Number | 7-236 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Tonya Wilbon FDA/OMPT/CDRH/OCE/DICE/PMCB/ 301-796-6224 tonya.wilbon@fda.hhs.gov |
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This document provides guidelines for performance, interpretation, and quality control of in vitro broth microdilution and agar dilution susceptibility tests for several antimicrobial agents suitable for use against Mycoplasma pneumoniae (M. pneumoniae), Mycoplasma hominis (M. hominis), and Ureaplasma species (Ureaplasma spp). Information in this document includes designated reference strains and the expected minimal inhibitory concentration ranges for specific drugs that should be obtained when they are tested.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.1700 | Culture Media, Antimicrobial Susceptibility Test | Class 2 | LKA |
| §866.1700 | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | Class 2 | JSO |
| §866.1700 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | Class 2 | JTZ |
| Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 2009. |