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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 021 FR Publication Date: 03/18/2009 

Part B: Supplementary Information

Recognition Number 7-189: CLSI M47-A, principles and procedures for blood cultures. (InVitro Diagnostics)

Date of Standard: 2007. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF MICROBIOLOGY (DMD)
Devices Affected:
Manual (broth, biphasic and lysis-centrifugation); automated (BACTEC, BatT/Alert and Versa/TREK) blood culture systems
Processes Affected:
510(k), Pre-IDE
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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
FDA Technical Contacts:
 Ribhi Shawar, Ph.D.
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5513
  Silver Spring MD 20993
  301/796-6698
  email: ribhi.shawar@fda.hhs.gov
 Alexandra Wong
  FDA/CDRH/OIR
  10993 New Hampshire Avenue Building 66, Room 5502
  Silver Spring MD 20993
  301/796-6210
  email: alexandra.wong@fda.hhs.gov
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