Recognized standard
M56-A
FDA recognition 7-257 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-257 |
|---|---|
| Designation | M56-A |
| Title | Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 1 |
| Scope (excerpt) | This document provides procedures for performing testing and providing accurate, reliable, and useful results to laboratories with differing levels of expertise in anaerobe bacteriology. Preexamination requirements for specimen selection, collection, transport, timely processing, and examination… |
At a glance
- 1–9 Product codes
- None 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: