Recognized standard
M50-A (Replaces M50-P)
FDA recognition 7-190 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-190 |
|---|---|
| Designation | M50-A (Replaces M50-P) |
| Title | Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 18, 2009 |
| Device classes | Class 1 |
| Scope (excerpt) | This standard includes a process for streamlined quality control (QC) of commercial microbial identification systems (MISs) that utilize multiple substrates and/or reagents to identify aerobic or anaerobic bacteria, yeasts, moulds, or yeastlike algae from culture. It specifies responsibilities of… |
At a glance
- 1–9 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: