Recognized standard
M47-A (Replaces M47-P)
FDA recognition 7-189 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-189 |
|---|---|
| Designation | M47-A (Replaces M47-P) |
| Title | Principles and Procedures for Blood Cultures; 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 document provides recommendations for the collection, transport, and processing of blood cultures as well as guidance for the recovery of pathogens from blood specimens taken from patients who are suspected of having bacteremia or fungemia. |
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: