Recognized standard
M47 2nd Edition
FDA recognition 7-322 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-322 |
|---|---|
| Designation | M47 2nd Edition |
| Title | Principles and Procedures for Blood Cultures |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This guideline is intended to provide recommendations to clinical microbiologists, other laboratorians (eg, pathologists, supervisors and/or managers, phlebotomists), and health care providers (HCPs) for recovering pathogens from the blood of patients with suspected bacteremia, mycobacteremia, or… |
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: