Recognized standard
M43-A October 2011
FDA recognition 7-236 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-236 |
|---|---|
| Designation | M43-A October 2011 |
| Title | Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This document contains standardized protocols for broth microdilution and agar dilution in vitro susceptibility testing for isolates of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma spp. It describes the optimum media formulations for use in broth microdilution and agar dilution assays… |
At a glance
- None 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: