Recognized standard
M52, 1st ed. August 2015 (Reaffirmed: January 2020)
FDA recognition 7-295 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-295 |
|---|---|
| Designation | M52, 1st ed. August 2015 (Reaffirmed: January 2020) |
| Title | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2019 |
| Scope (excerpt) | This guideline provides recommendations for clinical laboratory professionals for verification of commercial microbial identification systems (MIS) and US Food and Drug Administration (FDA)-cleared antimicrobial susceptibility testing systems (ASTS) to fulfill regulatory or QA requirements for use… |
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: