| CLSI MM13-A (Replaces MM13-P) Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline |
| Recognition Date | 2009-03-18 |
| Recognition List | 021 |
| Recognition Number | 7-191 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | InVitro Diagnostics |
| FDA Tech | David Goodwin FDA/OMPT/CDRH/OIR/DMD/BAC1/ 301-796-6932 David.Goodwin@fda.hhs.gov |
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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.
| 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 |
| There is no relevant guidance developed at this time. |