| CLSI M47-A (Replaces M47-P) Principles and Procedures for Blood Cultures; Approved Guideline |
| Recognition Date | 2009-03-18 |
| Recognition List | 021 |
| Recognition Number | 7-189 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | Ribhi Shawar FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6698 ribhi.shawar@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| §866.2560 | Monitor, Microbial Growth | Class 1 | JTA |
| §866.2560 | System, Blood Culturing | Class 1 | MDB |
| §866.2300 | Culture Media, Non-Selective And Non-Differential | Class 1 | JSG |
| There is no relevant guidance developed at this time. |