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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
Standard
CLSI  M47-A (Replaces M47-P)
Principles and Procedures for Blood Cultures; Approved Guideline
Scope/Abstract
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
§866.2300 Culture Media, Non-Selective And Non-Differential Class 1 JSG
§866.2560 Monitor, Microbial Growth Class 1 JTA
§866.2560 System, Blood Culturing Class 1 MDB
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ribhi Shawar
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC1/
  301-796-6698
  ribhi.shawar@fda.hhs.gov
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.
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