Recognized standard
MM06-A2 (Replaces MM06-A)
FDA recognition 7-238 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-238 |
|---|---|
| Designation | MM06-A2 (Replaces MM06-A) |
| Title | Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jan 15, 2013 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes and nucleic acid amplification techniques of the target sequences specific to particular microorganisms, and presents recommendations for quality assurance, proficiency testing… |
At a glance
- None 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: