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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 021 Date of Recognition 03/18/2009 
FR Recognition Number 7-191
CLSI MM13-A (Replaces MM13-P)
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline
This document provides guidance related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.2900 Device, Parasite Concentration Class 1 LKS
§866.2900 Device, Specimen Collection Class 1 LIO
§866.2900 System, Transport, Aerobic Class 1 JTW
§866.2900 Transport Systems, Anaerobic Class 1 JTX
§866.2390 Culture Media, Anaerobic Transport Class 1 JSL
§866.2390 Culture Media, Non-Propagating Transport Class 1 JSM
§866.2360 Culture Media, Selective Broth Class 1 JSD
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 David Goodwin
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics