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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 Entry 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
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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