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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 030 FR Publication Date: 01/15/2013 

Part B: Supplementary Information

Recognition Number 7-236: CLSI M43-A, methods for antimicrobial susceptibility testing for human mycoplasmas; approved guideline. (InVitro Diagnostics)

Date of Standard: 2011. 
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)
Devices Affected:
In Vitro Diagnostic Devices
Processes Affected:
510(k)
Type of Standard:
 Horizontal, National, Test Methods
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.1700 Culture Media, Antimicrobial Susceptibility Test Class 2 LKA
§866.1700 Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Class 2 JSO
§866.1700 Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth Class 2 JTZ
Relevant Guidance:
Class II Special Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, March 5, 2007

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080564.htm
FDA Technical Contact:
 Tonya Wilbon
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5663
  Silver Spring MD 20993
  301/796-6224
  email: tonya.wilbon@fda.hhs.gov
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