Recognized standard
MM09-A2 (Replaces MM09-A)
FDA recognition 7-255 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-255 |
|---|---|
| Designation | MM09-A2 (Replaces MM09-A) |
| Title | Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | Sequencing methods for genotyping have moved from the research laboratory into the clinical laboratory. Sequencing is an assay format of choice for very high-complexity genotyping, especially when hundreds or thousands of bases of genetic sequence are analyzed. Clinical and Laboratory Standards… |
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: