| CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts |
| Recognition Number | InVitro Diagnostics |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 7-278 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
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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 covers antifungal agent selection and preparation, test procedure implementation and interpretation, and quality control requirements for susceptibility testing of yeasts that cause invasive fungal infections.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.1700 | Culture Media, Antifungal, Susceptibility Test | Class 2 | MJE |
| §866.1640 | Susceptibility Test Plate, Antifungal | Class 2 | NGZ |
| §866.1620 | Discs, Elution | Class 2 | LTX |
| §866.1620 | Susceptibility Test Discs, Antimicrobial | Class 2 | JTN |
| Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs Guidance for Industry, Issued December 2017. |