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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 021 Date of Entry 03/18/2009 
FR Recognition Number 7-189
CLSI M47-A (Replaces M47-P)
Principles and Procedures for Blood Cultures; Approved Guideline
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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
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
FDA Technical Contact
 Ribhi Shawar
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.