Recognized standard
M58 1st Edition
FDA recognition 7-273 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-273 |
|---|---|
| Designation | M58 1st Edition |
| Title | Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | This guideline includes performance, reporting, and quality assurance recommendations for the identification of cultured microorganisms by medical laboratory professionals using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Recommendations for end-user verification… |
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: