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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 029 Date of Recognition 08/20/2012 
FR Recognition Number 7-146
Standard
CLSI M06-A2
Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard - Second Edition
Scope/Abstract
This document provides procedures for evaluating production lots of dehydrated Mueller-Hinton agar, and for developing and applying reference media.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.1640 Manual Antimicrobial Susceptibility Test Systems Class 2 JWY
§866.1620 Discs, Elution Class 2 LTX
§866.1620 Susceptibility Test Discs, Antimicrobial Class 2 JTN
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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