Recognized standard
MM17 2nd Edition
FDA recognition 7-289 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-289 |
|---|---|
| Designation | MM17 2nd Edition |
| Title | Verification and Validation of Multiplex Nucleic Acid Assays |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | This document discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: