Recognized standard
MM13 2nd Edition
FDA recognition 7-300 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-300 |
|---|---|
| Designation | MM13 2nd Edition |
| Title | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 1 |
| Scope (excerpt) | This guideline describes general technical principles for ensuring optimal specimen collection, transport, storage, and nucleic acid isolation for molecular diagnostic test methods. It is intended for all health care professionals responsible for obtaining and transporting specimens from patients or… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: